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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71104

35 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 22, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Wockhardt Usa Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

35 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 35

Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.

D-1243-2015
Recall number
D-1243-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
124,034 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015; Lot #: DM13117, Expiry: 10/31/2015; Lot #: DM13159, Expiry: 10/31/2015; Lot #: DM13186, Expiry: 10/31/2015; Lot #: DM13187, Expiry: 10/31/2015; Lot #: DM13188, Expiry: 10/31/2015; Lot #: DN10003, Expiry: 11/30/2015; Lot #: DN10045, Expiry: 11/30/2015; Lot #: DN10046, Expiry: 11/30/2015; Lot #: DN10389, Expiry: 1/31/2016; Lot #: DN10412, Expiry: 1/31/2016; Lot #: DN10604, Expiry: 1/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 2 of 35

Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1244-2015
Recall number
D-1244-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 149,924 Bottles and B) 35,012 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM10573, Expiry: 4/30/2015; Lot #: DM11531, Expiry: 5/31/2015; Lot #: DM11532, Expiry: 5/31/2015; Lot #: DM11676, Expiry: 6/30/2015; Lot #: DM11677, Expiry: 6/30/2015; Lot #: DM12543, Expiry: 8/31/2015; Lot #: DM13333, Expiry: 11/30/2015; Lot #: DN10272, Expiry: 12/31/2015; Lot #: DN10405, Expiry: 12/31/2015; Lot #: DN10446, Expiry: 1/1/2016. B) Lot #: DM11122, Expiry: 4/30/2015; Lot #: DM11130, Expiry: 4/30/2015; Lot #: DM11533, Expiry: 5/31/2015; Lot #: DM11674, Expiry: 6/30/2015; Lot #: DM11675, Expiry: 6/30/2015; Lot #: DM12497, Expiry: 8/31/2015; Lot #: DM13336, Expiry: 11/30/2015; Lot #: DN10289, Expiry: 12/31/2015; Lot #: DN10445, Expiry: 1/31/2016; Lot #: DN10816, Expiry: 1/31/2016; Lot #: DN10817, Expiry: 1/31/2016; Lot #: DN10976, Expiry: 2/29/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 3 of 35

Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.

D-1245-2015
Recall number
D-1245-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
5,910 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: DN10114, Expiry: 11/30/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 4 of 35

Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1246-2015
Recall number
D-1246-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
53,894 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM11488, Expiry: 4/30/2015; Lot #: DM12093, Expiry: 6/30/2015; Lot #: DM12540, Expiry: 7/31/2015. B) Lot #: DM11412, Expiry: 4/30/2015; Lot #: DM11642, Expiry: 5/31/2015; Lot #: DM11682, Expiry: 5/31/2015; Lot #: DM12094, Expiry: 6/30/2015; Lot #: DM12533, Expiry: 7/31/2015; Lot #: DM12609, Expiry: 7/31/2015; Lot #: DM12898, Expiry: 9/30/2015, Lot #: DM12899, Expiry: 9/30/2015; Lot #: DN10163, Expiry: 11/30/2015; Lot #: DN10273, Expiry: 11/30/2015; Lot #: DN10487, Expiry: 12/31/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 5 of 35

Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.

D-1247-2015
Recall number
D-1247-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
37,791 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: DM11802, Expiry: 6/30/2015; Lot #: DM11803, Expiry: 6/30/2015; Lot #: DM12273, Expiry: 7/31/2015; Lot #: DM12274, Expiry: 7/31/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 6 of 35

Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1248-2015
Recall number
D-1248-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 Cartons.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LM10712, Expiry: 4/30/2015; Lot #: LM10874, Expiry: 4/30/2015; Lot #: LM11040, Expiry: 5/31/2015; Lot #: LM11169, Expiry: 6/30/2015; Lot #: LM11401, Expiry: 6/30/2015; Lot #: LM12132, Expiry: 11/30/2015; Lot #: LN10039, Expiry: 12/31/2015; Lot #: LN10263, Expiry: 12/31/2015; Lot #: LN10276, Expiry: 12/31/2015; Lot #: LN10417, Expiry: 1/31/2016, Lot #: LN11365, Expiry: 8/31/2016. B) Lot #: LN11264, Expiry: 7/31/2015; Lot #: LN11373, Expiry: 8/31/2015; Lot #: LN11375, Expiry: 8/31/2015. C) Lot #: LM10686, Expiry: 4/30/2015; Lot #: LM10757, Expiry: 4/30/2015; Lot #: LM10855, Expiry: 4/30/2015; Lot #: LM10893, Expiry: 5/31/2015; Lot #: LM10945, Expiry: 5/31/2015; Lot #: LM10989, Expiry: 4/30/2015; Lot #: LM11117, Expiry: 6/30/2015; Lot #: LM11168, Expiry: 6/30/2015; Lot #: LM11214, Expiry: 6/30/2015; Lot #: LM11624, Expiry: 9/30/2015; Lot #: LM11797, Expiry: 10/31/2015; Lot #: LM11820, Expiry: 10/31/2015; Lot #: LM11959, Expiry: 10/31/2015; Lot #: LM12000, Expiry: 10/31/2015; Lot #: LM12027, Expiry: 11/30/2015; Lot #: LM12128, Expiry: 11/30/2015; Lot #: LN10014, Expiry: 11/30/2015; Lot #: LN10055, Expiry: 11/30/2015; Lot #: LN10089, Expiry: 11/30/2015; Lot #: LN10122, Expiry: 11/30/2015; Lot #: LN10156, Expiry: 12/31/2015; Lot #: LN10196, Expiry: 12/31/2015; Lot #: LN10225, Expiry: 12/31/2015; Lot #: LN10307, Expiry: 1/31/2016; Lot #: LN10338, Expiry: 1/31/2016; Lot #: LN10382, Expiry: 1/31/2016; Lot #: LN10416, Expiry: 1/31/2016; Lot #: LN10431, Expiry: 1/31/2016; Lot #: LN10461, Expiry: 1/31/2016; Lot #: LN10618, Expiry: 2/29/2016; Lot #: LN11144, Expiry: 5/31/2016; Lot #: LN11183, Expiry: 6/30/2016; Lot #: LN11236, Expiry: 6/30/2016; Lot #: LN11276, Expiry: 7/31/2016; Lot #: LN11347, Expiry: 7/31/2016; Lot #: LN11360, Expiry: 7/31/2016, Lot #: LN11366, Expiry: 8/31/2016; Lot #: LN11372, Expiry: 8/31/2016; Lot #: LN11395, Expiry: 9/30/2016; Lot #: LN11404, Expiry: 9/30/2016; Lot #: LN11419, Expiry: 9/30/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 7 of 35

Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.

D-1249-2015
Recall number
D-1249-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
59,729 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LM11172, Expiry: 6/30/2015; Lot #: LN10487, Expiry: 1/31/2016; Lot #: LN10488, Expiry: 1/31/2016; Lot #: LN10489, Expiry: 2/29/2016; Lot #: LN10578, Expiry: 2/29/2016; Lot #: LN10581, Expiry: 2/29/2016; Lot #: LN10582, Expiry: 2/29/2016; Lot #: LN11068, Expiry: 4/30/2016; Lot #: LN11073, Expiry: 4/30/2016; Lot #: LN11125, Expiry: 5/31/2016; Lot #: LN11362, Expiry: 8/31/2016; Lot #: LN11379, Expiry: 8/31/2016; Lot #: LN11380, Expiry: 8/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 8 of 35

Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1250-2015
Recall number
D-1250-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LM10806, Expiry: 5/31/2015; Lot #: LM11099, Expiry: 6/30/2015; Lot #: LM11297, Expiry: 7/31/2015; Lot #: LM11933, Expiry: 10/31/2015; Lot #: LN10180, Expiry: 12/31/2015; Lot #: LN10547, Expiry: 2/29/2016. B) Lot #: LM10784, Expiry: 5/31/2015; Lot #: LM10791, Expiry: 5/31/2015; Lot #: LM10812, Expiry: 5/31/2015; Lot #: LM11112, Expiry: 6/30/2015; Lot #: LM11298, Expiry: 7/31/2015; Lot #: LM11299, Expiry: 7/31/2015; Lot #: LM11625, Expiry: 8/31/2015; Lot #: LN10182, Expiry: 12/31/2015; Lot #: LN10548, Expiry: 2/29/2016; Lot #: LN11115, Expiry: 5/31/2016; Lot #: LN11367, Expiry: 8/31/2016; Lot #: LN11369, Expiry: 8/31/2016. C) Lot #: LM10813, Expiry: 5/31/2015; Lot #: LM11085, Expiry: 6/30/2015; Lot #: LM11088, Expiry: 6/30/2015; Lot #: LM11296, Expiry: 7/31/2015; Lot #: LM11932, Expiry: 10/31/2015; Lot #: LN10181, Expiry: 12/31/2015; Lot #: LN10549, Expiry: 2/29/2016; Lot #: LN11114, Expiry: 5/31/2016; Lot #: LN11359, Expiry: 8/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 9 of 35

Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00.

D-1251-2015
Recall number
D-1251-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
848 Pouches

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LN11086, Expiry: 5/31/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 10 of 35

Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA .

D-1252-2015
Recall number
D-1252-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 33,422 Bottles and B) 940 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LN10978, Expiry: 4/30/2015; Lot #: LN11007, Expiry: 4/30/2015; Lot #: LN11013, Expiry: 4/30/2015; Lot #: LN11258, Expiry: 6/30/2015; Lot #: LN11259, Expiry: 6/30/2015; Lot #: LN11277, Expiry: 6/30/2015; Lot #: LN11317, Expiry: 6/30/2015. B) Lot #: LN11255, Expiry: 6/30/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 11 of 35

Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1253-2015
Recall number
D-1253-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
407,958 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LN10896, Expiry: 4/30/2015; Lot #: LN10901, Expiry: 4/30/2015; Lot #:LN10902, Expiry: 4/30/2015; Lot #: LN10903, Expiry: 4/30/2015; Lot #: LN11020, Expiry: 5/31/2015; Lot #: LN11021, Expiry: 5/31/2015; Lot #: LN11055, Expiry: 5/31/2015; Lot #: LN11056, Expiry: 5/31/2015; Lot #: LN11149, Expiry: 5/31/2015, Lot #: LN11150, Expiry: 5/31/2015; Lot #: LN11267, Expiry: 6/30/2015; Lot #: LN11357, Expiry: 7/31/2015; Lot #: LN11387, Expiry: 8/31/2015; Lot #: LN11421, Expiry: 9/30/2015. B) Lot #: LN10808, Expiry: 4/30/2015; Lot #: LN11083, Expiry: 5/31/2015; Lot #: LN11084, Expiry: 5/31/2015; Lot #: LN11085, Expiry: 5/31/2015; Lot #: LN11089, Expiry: 5/31/2015; Lot #: LN11109, Expiry: 5/31/2015; Lot #: LN11110, Expiry: 5/31/2015, Lot #: LN11120, Expiry: 5/31/2015; Lot #: LN11121, Expiry: 5/31/2015; Lot #: LN11186, Expiry: 5/31/2015; Lot #: LN11187, Expiry: 6/30/2015; Lot #: LN11188, Expiry: 6/30/2015; Lot #: LN11206, Expiry: 6/30/2015; Lot #: LN11226, Expiry: 6/30/2015; Lot #: LN11227, Expiry: 6/30/2015; Lot #: LN11233, Expiry: 6/30/2015; Lot #: LN11251, Expiry: 6/30/2015; Lot #: LN11257, Expiry: 6/30/2015; Lot #: LN11262, Expiry: 7/31/2015; Lot #: LN11263, Expiry:7/31/2015; Lot #: LN11274, Expiry: 7/31/2015; Lot#: LN11288, Expiry: 7/31/2015; Lot #: LN11370; Expiry: 8/31/2015; Lot #: LN11371, Expiry: 8/31/2015; Lot #: LN11378, Expiry: 8/31/2015; Lot #: LN11384, Expiry: 8/31/2015; Lot #: LN11400, Expiry: 9/30/2015; Lot #: LN11402, Expiry: 9/30/2015; Lot #: LN11406, Expiry: 9/30/2015; Lot #: LN11412, Expiry: 9/30/2015; Lot #: LN11416, Expiry: 9/30/2015; Lot #: LN11428, Expiry: 9/30/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 12 of 35

Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.

D-1254-2015
Recall number
D-1254-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
491,360 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LM10776, Expiry: 5/31/2015; Lot #: LM10781, Expiry: 5/31/2015; Lot #: LM10783, Expiry: 5/31/2015; Lot #: LM10923, Expiry: 4/30/2015; Lot #: LM10924, Expiry: 4/30/2015; Lot #: LM10925, Expiry: 4/30/2015; Lot #: LM10926, Expiry: 5/31/2015; Lot #: LM10927, Expiry: 5/31/2015; Lot #: LM10937, Expiry: 6/30/2015; Lot #: LM11138, Expiry: 6/30/2015; Lot #: LM11139, Expiry: 6/30/2015; Lot #: LM11141, Expiry: 6/30/2015; Lot #: LM11180, Expiry: 6/30/2015; Lot #: LM11181, Expiry: 6/30/2015; Lot #: LM11319, Expiry: 7/31/2015; Lot #: LM11320, Expiry: 7/31/2015; Lot #: LM11356, Expiry: 7/31/2015; Lot #: LM11357, Expiry: 7/31/2015; Lot #: LM11363, Expiry: 7/31/2015; Lot #: LM11407, Expiry: 7/31/2015; Lot #: LM11558, Expiry: 8/31/2015; Lot #: LM11730, Expiry: 9/30/2015; Lot #: LM11737, Expiry: 9/30/2015; Lot #: LM11744, Expiry: 9/30/2015, Lot #: LM11754, Expiry: 9/30/2015; Lot #: LM11860, Expiry: 10/31/2015; Lot #: LM11861, Expiry: 10/31/2015; Lot #: LM11904, Expiry: 10/31/2015; Lot #: LM11905, Expiry: 10/31/2015; Lot #: LM11906, Expiry: 10/31/2015; Lot #: LM11964, Expiry: 11/30/2015; Lot #: LN10127, Expiry: 12/31/2015; Lot #: LN10128, Expiry: 12/31/2015; Lot #: LN10137, Expiry: 12/31/2015; Lot #: LN10138, Expiry: 12/31/2015; Lot #: LN10139, Expiry: 12/31/2015; Lot #: LN10140, Expiry: 12/31/2015; Lot #: LN10223, Expiry: 12/31/2015; Lot #: LN10224, Expiry: 12/31/2015; Lot #: LN10235, Expiry: 1/31/2016; Lot #: LN10236, Expiry: 1/31/2016; Lot #: LN10361, Expiry: 1/31/2016; Lot #: LN10362, Expiry: 1/31/2016; Lot #: LN10550, Expiry: 2/29/2016; Lot #: LN10551, Expiry: 2/29/2016; Lot #: LN10552, Expiry: 2/29/2016; Lot #: LN10553, Expiry: 2/29/2016; Lot #: LN10554, Expiry: 2/29/2016; Lot #: LN10606, Expiry: 2/29/2016; Lot #: LN10613, Expiry: 2/29/2016; Lot #: LN10681, Expiry: 3/31/2016; Lot #: LN10752, Expiry: 3/31/2016; Lot #: LN10753, Expiry: 3/31/2016; Lot #: LN10847, Expiry: 4/30/2016; Lot #: LN10944, Expiry: 4/30/2016; Lot #: LN10954, Expiry: 4/30/2016; Lot #: LN10955, Expiry: 4/30/2016; Lot #: LN11091, Expiry: 5/31/2016; Lot #: LN11092, Expiry: 5/31/2016; Lot #: LN11104, Expiry: 5/31/2016; Lot #: LN11112, Expiry: 5/31/2016; Lot #: LN11231, Expiry: 6/30/2016; Lot #: LN11232, Expiry: 6/30/2016; Lot #: LN11241, Expiry: 7/31/2016; Lot #: LN11282, Expiry: 7/31/2016; Lot #: LN11355, Expiry: 8/31/2016; Lot #: LN11358, Expiry: 8/31/2016; Lot #: LN11361, Expiry: 8/31/2016; Lot #: LN11399, Expiry: 9/30/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 13 of 35

Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1255-2015
Recall number
D-1255-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 146,959 Bottles, B) 73,445 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM11421, Expiry: 5/31/2015; Lot #: DM12956, Expiry: 10/31/2015; Lot #: DM12957, Expiry: 10/31/2015; Lot #: DM12963, Expiry: 10/31/2015; Lot #: DM13242, Expiry: 11/30/2015; Lot #: DM13243, Expiry: 11/30/2015; Lot #: DM13251, Expiry: 11/30/2015; Lot #: DM13260, Expiry: 11/30/2015; Lot #: DN10138, Expiry: 12/31/2015. B) Lot #: DM11035, Expiry: 4/30/2015; Lot #: DM11088, Expiry: 4/30/2015; Lot #: DM11389, Expiry: 5/31/2015; Lot #: DM11393, Expiry: 5/31/2015; Lot #: DM11394, Expiry: 5/31/2015; Lot #: DM12632, Expiry: 9/30/2015; Lot #: DM12633, Expiry: 9/30/2015; Lot #: DM12650, Expiry: 9/30/2015; Lot #: DM12651, Expiry: 9/30/2015; Lot #: DM12667, Expiry: 5/31/2015; Lot #: DM12964, Expiry: 10/31/2015; Lot #: DM13086, Expiry: 10/31/2015; Lot #: DM13155, Expiry: 10/31/2015; Lot #: DM13156, Expiry: 10/31/2015; Lot #: DM13157, Expiry: 10/31/2015; Lot #: DM13158, Expiry: 10/31/2015; Lot #: DM13184, Expiry: 10/31/2015; Lot #: DM13206, Expiry: 10/31/2015; Lot #: DM13207, Expiry: 10/31/2015; Lot #: DM13266, Expiry: 11/30/2015; Lot #: DM13267, Expiry: 11/30/2015; Lot #: DM13268, Expiry: 11/30/2015; Lot #: DM13283, Expiry: 11/30/2015; Lot #: DM13325, Expiry: 11/30/2015; Lot #: DN10058, Expiry: 12/31/2015; Lot #: DN10059; Expiry: 12/31/2015; Lot #: DN10060, Expiry: 12/31/2015; Lot #: DN10061, Expiry: 12/31/2015; Lot #: DN10062, Expiry: 12/31/2015; Lot #: DN10307, Expiry: 12/31/2015; Lot #: DN10308, Expiry: 12/31/2015; Lot #: DN10324, Expiry: 12/31/2015; Lot #: DN10346, Expiry: 12/31/2015; Lot #: DN10809, Expiry: 2/29/2016; Lot #: DN10810, Expiry: 2/29/2016; Lot #: DN10840, Expiry: 2/29/2016; Lot #: DN10877, Expiry: 2/29/2016; Lot #: DN10878, Expiry: 2/29/2016; Lot #: DN10904, Expiry: 2/29/2016; Lot #: DN10905, Expiry: 2/29/2016; Lot #: DN10921, Expiry: 2/29/2016; Lot #: DN10942, Expiry: 3/31/2016; Lot #: DN10943, Expiry: 3/31/2016; Lot #: DN10972, Expiry: 3/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 14 of 35

Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1256-2015
Recall number
D-1256-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 152,164 Bottles and B) 50,991 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM12975, Expiry: 10/31/2015; Lot #: DM12976, Expiry: 10/31/2015; Lot #: DM12977, Expiry:10/31/2015; Lot #: DM12986, Expiry: 10/31/2015; Lot #: DM13259. Expiry: 10/31/2015; Lot #: DM13269, Expiry: 10/31/2015; Lot #: DM13270, Expiry: 11/30/2015; Lot #: DM13275, Expiry: 11/30/2015; Lot #: DM13339, Expiry: 11/30/2015; Lot #: DM13341, Expiry: 11/30/2015; Lot #: DM13369, Expiry: 11/30/2015; Lot #: DM13370, Expiry: 11/30/2015; Lot #: DN10088, Expiry: 12/31/2015; Lot #: DN10099, Expiry: 12/31/2015; Lot #: DN10939, Expiry: 3/31/2016; Lot #: DN10940, Expiry: 3/31/2016. B) Lot #: DM11422, Expiry: 5/31/2015; Lot #: DM11423, Expiry: 5/31/2015; Lot #: DM11424, Expiry: 5/31/2015; Lot #: DM11425, Expiry: 5/31/2015; Lot #: DM12634, Expiry: 9/30/2015; Lot #: DM12635; Expiry: 9/30/2015; Lot #: DM12660, Expiry: 9/30/2015; Lot #: DM12661, Expiry: 9/30/2015; Lot #: DM12662, Expiry: 9/30/2015; Lot #: DM12663, Expiry: 9/30/2015; Lot #: DM12673, Expiry: 9/30/2015; Lot #: DM12674, Expiry: 9/30/2015; Lot #: DM12684, Expiry: 9/30/2015; Lot #: DM12685, Expiry: 9/30/2015; Lot #: DM12985, Expiry: 10/31/2015; Lot #: DM13162, Expiry: 10/31/2015; Lot #: DM13163, Expiry: 10/31/2015; Lot #: DM13195, Expiry: 10/31/2015; Lot #: DM13196, Expiry: 10/31/2015; Lot #: DM13222, Expiry: 10/31/2015; Lot #: DM13223, Expiry: 10/31/2015; Lot #: DM13271, Expiry: 11/30/2015; Lot #: DM13272, Expiry: 11/30/2015; Lot #: DM13273, Expiry: 11/30/2015; Lot #: DM13274, Expiry: 11/30/2015; Lot #: DM13281, Expiry: 11/30/2015; Lot #: DM13282, Expiry: 11/30/2015; Lot #: DM13296, Expiry: 11/30/2015; Lot #: DM13297, Expiry: 11/30/2015: Lot #: DM13393, Expiry: 11/30/2015; Lot #: DM13394, Expiry: 11/30/2015; Lot #: DM13395, Expiry: 11/30/2015; Lot #: DM13403, Expiry: 11/30/2015; Lot #: DM13404, Expiry: 11/30/2015; Lot #: DM13415, Expiry: 11/30/2015; Lot #: DM13429, Expiry: 11/30/2015; Lot #: DN10077, Expiry: 12/31/2015; Lot #: DN10078, Expiry: 12/31/2015; Lot #: DN10079, Expiry: 12/31/2015; Lot #: DN10080, Expiry: 12/31/2015; Lot #: DN10081, Expiry: 12/31/2015; Lot #: DN10100, Expiry: 12/31/2015; Lot #: DN10104, Expiry: 12/31/2015; Lot #: DN10105, Expiry: 12/31/2015, Lot #: DN10336, Expiry: 12/31/2015; Lot #: DN10342, Expiry: 12/31/2015; Lot #: DN10343, Expiry: 12/31/2015; Lot #: DN10344, Expiry: 12/31/2015; Lot #: DN10355, Expiry: 12/31/2015; Lot #: DN10356, Expiry: 12/31/2015; Lot #: DN10811, Expiry: 2/29/2016; Lot #: DN10812, Expiry: 2/29/2016; Lot # DN10830, Expiry: 2/29/2016; Lot #: DN10874, Expiry: 2/29/2016; Lot #: DN10875, Expiry: 2/29/2016; Lot #: DN10876, Expiry: 2/29/2016; Lot #: DN10890, Expiry: 2/29/2016; Lot #: DN10891, Expiry: 2/29/2016; Lot #: DN10938, Expiry: 3/31/2016; Lot #: DN10956, Expiry: 3/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 15 of 35

Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1257-2015
Recall number
D-1257-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM10991, Expiry: 4/30/2015; Lot #: DM11226, Expiry: 4/30/2015; Lot #: DM11665, Expiry: 6/30/2015; Lot #: DM11810, Expiry: 6/30/2015; Lot #: DM12702, Expiry: 9/30/2015; Lot #: DN10719, Expiry: 1/31/2016. B) Lot #: DM11651, Expiry: 6/30/2015; Lot #: DM11652, Expiry: 6/30/2015; Lot #: DM11664, Expiry: 6/30/2015; Lot #: DM12701, Expiry: 9/30/2015; Lot #: DN10139, Expiry: 12/31/2015. C) Lot #: DM11041, Expiry: 4/30/2015; Lot #: DM11267, Expiry: 4/30/2015; Lot #: DM11268, Expiry: 4/30/2015; Lot #: DM11279, Expiry: 5/31/2015; Lot #: DM11286, Expiry: 5/31/2015; Lot #: DM11292, Expiry: 5/31/2015; Lot #: DM11625, Expiry: 6/30/2015; Lot #: DM11626, Expiry: 6/30/2015; Lot #: DM11670, Expiry: 6/30/2015; Lot #: DM11772, Expiry: 6/30/2015; Lot #: DM11773, Expiry: 6/30/2015; Lot #: DM11809, Expiry: 6/30/2015; Lot #: DM12698, Expiry: 9/30/2015; Lot #: DN10110, Expiry: 11/30/2015; Lot #: DN10608, Expiry: 1/31/2016; Lot #: DN10642, Expiry: 1/31/2016; Lot #: DN10694, Expiry: 1/31/2016; Lot #: DN10744, Expiry: 1/31/2016; Lot #: DN10799, Expiry: 1/31/2016; Lot #: DN10839; Expiry: 2/29/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 16 of 35

Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1258-2015
Recall number
D-1258-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 133,920 Bottles, B) 6705 Bottles, and C) 137,659 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM11197, Expiry: 4/30/2015; Lot #: DM11202, Expiry: 4/30/2015; Lot #: DM11641, Expiry: 6/30/2015; Lot #: DM12237, Expiry: 8/31/2015; Lot #: DM12238, Expiry: 8/31/2015, Lot #: DM12285, Expiry: 8/31/2015; Lot #: DN10176, Expiry: 12/31/2015; Lot #: DN10636, Expiry: 1/31/2016; Lot #: DN10869, Expiry: 2/29/2016. B) Lot #: DM11646, Expiry: 6/30/2015; Lot #: DM12364, Expiry: 8/31/2015. C) Lot #: DM11136, Expiry: 4/30/2015; Lot #: DM11137, Expiry: 4/30/2015; Lot #: DM11142, Expiry: 4/30/2015; Lot #: DM11150, Expiry: 4/30/2015; Lot #: DM11176, Expiry: 4/30/2015; Lot #: DM11212, Expiry: 4/30/2015; Lot #: DM11213, Expiry: 5/31/2015; Lot #: DM11214, Expiry: 5/31/2015; Lot #: DM11222, Expiry: 5/31/2015; Lot #: DM11223, Expiry: 5/31/2015; Lot #: DM11270, Expiry: 5/31/2015; Lot #: DM11277, Expiry: 5/31/2015; Lot #: DM11278, Expiry: 5/31/2015; Lot #: DM11289, Expiry: 5/31/2015; Lot #: DM11290, Expiry: 5/31/2015; Lot #: DM11291, Expiry: 5/31/2015; Lot #: DM11322, Expiry: 5/31/2015; Lot #: DM11499, Expiry: 5/31/2015; Lot #: DM11538, Expiry: 5/31/2015; Lot #: DM11539, Expiry: 5/31/2015; Lot #: DM11540, Expiry: 5/31/2015, Lot #: DM11541, Expiry: 5/31/2015; Lot #: DM11542, Expiry: 5/31/2015; Lot #: DM11543, Expiry: 5/31/2015; Lot #: DM11601, Expiry: 6/30/2015; Lot #: DM11602, Expiry: 6/30/2015; Lot #: DM11617, Expiry: 6/30/2015; Lot #: DM11623, Expiry: 6/30/2015; Lot #: DM11624, Expiry: 6/30/2015; Lot #: DM11825, Expiry: 6/30/2015; Lot #: DM11826, Expiry: 6/30/2015; Lot #: DM11831, Expiry: 6/30/2015; Lot #: DM11875, Expiry: 6/30/2015; Lot #: DM11876, Expiry: 6/30/2015; Lot #: DM11877, Expiry: 6/30/2015; Lot #: DM11878, Expiry: 6/30/2015: Lot #: DM11883, Expiry: 6/30/2015, Lot #: DM11918, Expiry: 6/30/2015; Lot #: DM11919, Expiry: 6/30/2015; Lot #: DM11922, Expiry: 7/31/2015; Lot #: DM11923, Expiry: 7/31/2015; Lot #: DM11962, Expiry: 7/31/2015; Lot #: DM11963, Expiry: 7/31/2015; Lot #: DM12248, Expiry: 8/31/2015; Lot #: DM12249, Expiry: 8/31/2015; Lot #: DM12263, Expiry: 8/31/2015: Lot #: DM12306, Expiry: 8/31/2015; Lot #: DM12317, Expiry: 8/31/2015; Lot #: DM12349, Expiry: 8/31/2015; Lot #: DM12350, Expiry: 8/31/2015; Lot #: DM12351, Expiry: 8/31/2015; Lot #: DM12388, Expiry: 8/31/2015; Lot #: DM12389, Expiry: 8/31/2015; Lot #: DM13100, Expiry: 9/30/2015; Lot #: DM13052, Expiry: 9/30/2015; Lot #: DM13053, Expiry: 9/31/2015; Lot #: DM13101, Expiry: 9/30/2015; Lot #: DM13354, Expiry: 9/30/2015; Lot #: DN10148, Expiry: 11/30/2015; Lot #: DN10152, Expiry: 11/30/2015; Lot #: DN10154, Expiry: 12/31/2015; Lot #: DN10155, Expiry: 12/31/2015; Lot #: DN10175, Expiry: 12/31/2015; Lot #: DN10180; Expiry: 12/31/2015; Lot #: DN10185, Expiry: 12/31/2015; Lot #: DN10195, Expiry: 12/31/2015; Lot #: DN10204, Expiry: 12/31/2015; Lot #: DN10213, Expiry: 12/31/2015; Lot #: DN10594, Expiry: 1/31/2016; Lot #: DN10595, Expiry: 1/31/2016; Lot #: DN10606, Expiry: 1/31/2016; Lot #: DN10607, Expiry: 1/31/2016; Lot #: DN10630, Expiry: 1/31/2016; Lot #: DN10637, Expiry: 1/31/2016; Lot #: DN10638, Expiry: 1/31/2016; Lot #: DN10767, Expiry: 2/29/2016; Lot #: DN10768, Expiry: 2/29/2016; Lot #: DN10769, Expiry: 9/30/2015; Lot #: DN10777, Expiry: 2/29/2016; Lot #: DN10782, Expiry: 2/29/2016; Lot #: DN10783, Expiry: 1/31/2016; Lot #: DN10784, Expiry: 2/29/2016; Lot #: DN10834, Expiry: 2/29/2016; Lot #: DN10835, Expiry: 2/29/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 17 of 35

Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1259-2015
Recall number
D-1259-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 121,608 Bottles, B) 11,000 Bottles, and C) 152,773 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM11334, Expiry: 4/30/2015; Lot #: DM11551, Expiry: 6/30/2015; Lot #: DM11995, Expiry: 7/31/2015; Lot #: DM12007, Expiry: 7/31/2015; Lot #: DM12480, Expiry: 8/31/2015; Lot #: DN10255, Expiry: 12/31/2015; Lot #: DN10410, Expiry: 1/31/2016; Lot #: DN10897, Expiry: 2/29/2016. B) Lot #: DM11556, Expiry: 6/30/2015; Lot #: DM11567, Expiry: 6/30/2015; Lot #: DM12008, Expiry: 7/31/2015; Lot #: DM12482, Expiry: 8/31/2015. C) Lot #: DM11119, Expiry: 4/30/2015; Lot #: DM11131, Expiry: 4/30/2015; Lot #: DM11132, Expiry: 4/30/2015; Lot #: DM11144, Expiry: 4/30/2015; Lot #: DM11145, Expiry: 4/30/2015; Lot #: DM11161, Expiry: 4/30/2015; Lot #: DM11162, Expiry: 4/30/2015; Lot #: DM11181, Expiry: 4/30/2015; Lot #: DM11182, Expiry: 4/30/2015; Lot #: DM11185, Expiry: 4/30/2015; Lot #: DM11335, Expiry: 5/31/2015; Lot #: DM11352, Expiry: 5/31/2015; Lot #: DM11357, Expiry: 5/31/2015; Lot #: DM11358, Expiry: 5/31/2015: Lot #: DM11366, Expiry: 5/31/2015; Lot #: DM11367, Expiry: 5/31/2015: Lot #: DM11390, Expiry: 5/31/2015; Lot #: DM11396, Expiry: 5/31/2015; Lot #: DM11397, Expiry: 5/31/2015; Lot #: DM11407, Expiry: 5/31/2015; Lot #: DM11408, Expiry: 5/31/2015; Lot #: DM11410, Expiry: 5/31/2015; Lot #: DM11427, Expiry: 5/31/2015; Lot #: DM11428, Expiry: 5/31/2015; Lot #: DM11443, Expiry: 5/31/2015; Lot #: DM11983, Expiry: 7/31/2015; Lot #: DM11984, Expiry: 7/31/2015; Lot #: DM11985, Expiry: 7/31/2015; Lot #: DM11986, Expiry: 7/31/2015; Lot #: DM11996, Expiry: 7/31/2015; Lot #: DM12005, Expiry: 7/31/2015; Lot #: DM12006, Expiry: 7/31/2015; Lot #: DM12045, Expiry: 7/31/2015; Lot #: DM12046, Expiry: 7/31/2015; Lot #: DM12056, Expiry: 7/31/2015; Lot #: DM12057, Expiry: 7/31/2015; Lot #: DM12061, Expiry: 7/31/2015; Lot #: DM12065, Expiry: 7/31/2015; Lot #: DM12079, Expiry: 7/31/2015; Lot #: DM12080, Expiry: 7/31/2015; Lot #: DM12453, Expiry: 8/31/2015; Lot #: DM12455, Expiry: 8/31/2015; Lot #: DM12466, Expiry: 8/31/2015; Lot #: DM12467, Expiry: 8/31/2015; Lot #: DM12478, Expiry: 8/31/2015; Lot #: DM12479, Expiry: 8/31/2015; Lot #: DM13072, Expiry: 10/31/2015; Lot #: DM13093, Expiry: 10/31/2015; Lot #: DM13098, Expiry: 10/31/2015; Lot #: DM13099, Expiry: 10/31/2015; Lot #: DM13220, Expiry: 10/31/2015; Lot #: DM13221, Expiry: 10/31/2015; Lot #: DM13362, Expiry: 11/30/2015; Lot #: DM13363, Expiry: 11/30/2015; Lot #: DM13386, Expiry: 11/30/2015; Lot #: DM13392, Expiry: 11/30/2015; Lot #: DM13414, Expiry: 11/30/2015: Lot #: DM13441, Expiry: 11/30/2015; Lot #: DM13454, Expiry: 11/30/2015; Lot #: DN10253, Expiry: 12/31/2015; Lot #: DN10254, Expiry: 12/31/2015; Lot #: DN10261, Expiry: 12/31/2015; Lot #: DN10262, Expiry: 12/31/2015; Lot #: DN10282, Expiry: 12/31/2015; Lot #: DN10283, Expiry: 12/31/2015; Lot #: DN10284, Expiry: 12/31/2015; Lot #: DN10293, Expiry: 12/31/2015; Lot #: DN10294, Expiry: 12/31/2015; Lot #: DN10295, Expiry: 12/31/2015; Lot #: DN10309, Expiry: 12/31/2015; Lot #: DN10411, Expiry: 1/31/2016; Lot #: DN10455, Expiry: 1/31/2016; Lot #: DN10464, Expiry: 1/31/2016; Lot #: DN10485, Expiry: 1/31/2016; Lot #: DN10497, Expiry: 1/31/2016; Lot #: DN10505, Expiry: 1/31/2016; Lot #: DN10506, Expiry: 1/31/2016; Lot #: DN10524, Expiry: 1/31/2016; Lot #: DN10534, Expiry: 1/31/2016; Lot #: DN10535, Expiry: 1/31/2016; Lot #: DN10554, Expiry: 1/31/2016; Lot #: DN10555, Expiry: 1/31/2016; Lot #: DN10909, Expiry: 2/29/2016; Lot #: DN10910, Expiry: 2/29/2016; Lot #: DN10923, Expiry: 2/29/2016; Lot #: DN10928, Expiry: 3/31/2016; Lot #: DN10929, Expiry: 3/31/2016; Lot #: DN10954, Expiry: 3/31/2016; Lot #: DN10970, Expiry: 3/31/2016; Lot #: DN10971, Expiry: 3/31/2016; Lot #: DN10986, Expiry: 3/31/2016; Lot #: DN10987, Expiry: 3/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 18 of 35

Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1260-2015
Recall number
D-1260-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 63,203 Bottles and B) 6,094 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM11003, Expiry: 4/30/2015; Lot #: DM11094, Expiry: 4/30/2015; Lot #: DM11689, Expiry: 6/30/2015; Lot #: DM11873, Expiry: 6/30/2015; Lot #: DM11874, Expiry: 6/30/2015; Lot #: DM12402, Expiry: 8/31/2015; Lot #: DM12412, Expiry: 8/31/2015; Lot #: DM13440, Expiry: 11/30/2015; Lot #: DN10689, Expiry: 1/31/2016; Lot #: DN10693, Expiry: 1/31/2016. B) Lot #: DM11095, Expiry: 4/30/2015; Lot #: DM11688, Expiry: 6/30/2015; Lot #: DM11860, Expiry: 6/30/2015; Lot #: DM12413, Expiry: 8/31/2015; Lot #: DN10692, Expiry: 1/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 19 of 35

Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1261-2015
Recall number
D-1261-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 174,571 Bottles, B) 66,960 Bottles, and C) 48,988 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM11040, Expiry: 4/30/2015; Lot #: DM11463, Expiry: 5/31/2015; Lot #: DM11497, Expiry: 5/31/2015; Lot #: DM11498, Expiry: 5/31/2015; Lot #: DM12126, Expiry: 7/31/2015; Lot #: DM12132, Expiry: 7/31/2015; Lot #: DM12172, Expiry: 7/31/2015; Lot #: DM12176, Expiry: 7/31/2015; Lot #: DN10325, Expiry: 12/31/2015; Lot #: DN10892, Expiry: 2/29/2016. B) Lot #: DM11812, Expiry: 6/30/2015; Lot #: DM11816, Expiry: 6/30/2015; Lot #: DM11821, Expiry: 6/30/2015; Lot #: DM11822, Expiry: 6/30/2015; Lot #: DM11827, Expiry: 6/30/2015; Lot #: DM11828, Expiry: 6/30/2015; Lot #: DM11853, Expiry: 6/30/2015; Lot #: DM11856, Expiry: 6/30/2015; Lot #: DM12517, Expiry: 8/31/2015; Lot #: DM12519, Expiry: 8/31/2015; Lot #: DM12528, Expiry: 8/31/2015; Lot #: DM12529, Expiry: 8/31/2015; Lot #: DM12534, Expiry: 8/31/2015; Lot #: DM12535, Expiry: 8/31/2015. C) Lot #: DM11018, Expiry: 4/30/2015; Lot #: DM11019, Expiry: 4/30/2015; Lot #: DM11028, Expiry: 4/30/2015; Lot #: DM11029, Expiry: 4/30/2015; Lot #: DM11049, Expiry: 4/30/2015; Lot #: DM11050, Expiry: 4/30/2015; Lot #: DM11468, Expiry: 5/31/2015; Lot #: DM11469, Expiry: 5/31/2015; Lot #: DM11480, Expiry: 5/31/2015; Lot #: DM11483, Expiry: 5/31/2015; Lot #: DM12087, Expiry: 7/31/2015; Lot #: DM12095, Expiry: 7/31/2015; Lot #: DM12112, Expiry: 7/31/2015; Lot #: DM12129, Expiry: 7/31/2015; Lot #: DM12140, Expiry: 7/31/2015; Lot #: DM12141, Expiry: 7/31/2015; Lot #: DM12177, Expiry: 7/31/2015; Lot #: DM12499, Expiry: 8/31/2015; Lot #: DM12505, Expiry: 8/31/2015; Lot #: DM12509, Expiry: 8/31/2015; Lot #: DM12510, Expiry: 8/31/2015; Lot #: DM13306, Expiry: 11/30/2015; Lot #: DM13307, Expiry: 11/30/2015; Lot #: DM13313, Expiry: 11/30/2015; Lot #: DN10316, Expiry: 12/31/2015; Lot #: DN10332, Expiry: 12/31/2015; Lot #: DN10333, Expiry: 12/31/2015; Lot #: DN10348, Expiry: 12/31/2015; Lot #: DN10353, Expiry: 12/31/2015; Lot #: DN10369, Expiry: 12/31/2015; Lot #: DN10374, Expiry: 12/31/2015; Lot #: DN10375, Expiry: 12/31/2015; Lot #: DN10396, Expiry: 12/31/2015; Lot #: DN10854, Expiry: 2/29/2016; Lot #: DN10855, Expiry: 2/29/2016; Lot #: DN10872, Expiry: 2/29/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 20 of 35

Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1262-2015
Recall number
D-1262-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 36,213 Bottles and B) 12,824 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: DM11608, Expiry: 5/31/2015; Lot #: DM11609, Expiry: 5/31/2015; Lot #: DN10190, Expiry: 12/31/2015. B) Lot #: DM11186, Expiry: 4/30/2015; Lot #: DM11607, Expiry: 5/31/2015; Lot #: DM13298, Expiry: 10/31/2015; Lot #: DN10188, Expiry: 12/31/2015; Lot #: DN10189, Expiry: 12/31/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 21 of 35

Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1263-2015
Recall number
D-1263-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 112,120 Bottles and B) 178,580 Cartons.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LM10739, Expiry: 4/30/2015; Lot #: LM10991, Expiry: 5/31/2015; Lot #: LM11264, Expiry: 6/30/2015; Lot #: LM12019, Expiry: 11/30/2015; Lot #: LN10100, Expiry: 12/31/2015; Lot #: LN10220, Expiry: 12/31/2015; Lot #: LN10227, Expiry: 12/31/2015; Lot #: LN10228, Expiry: 12/31/2015; Lot #: LN11405, Expiry: 9/30/2016. B) Lot #: LM11015, Expiry: 5/31/2015; Lot #: LM11609, Expiry: 9/30/2015; Lot #: LM11883, Expiry: 10/31/2015; Lot #: LM11918, Expiry: 10/31/2015; Lot #: LN10274, Expiry: 12/31/2015; Lot #: LN11045, Expiry: 4/30/2016; Lot #: LN11327, Expiry: 12/31/2015; Lot #: LN11332, Expiry: 7/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 22 of 35

Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.

D-1264-2015
Recall number
D-1264-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
7,584 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LN10991, Expiry: 4/30/2015; Lot #: LN11381, Expiry: 7/31/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 23 of 35

Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1265-2015
Recall number
D-1265-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 69,008 Bottles, B) 399,730 Bottles, and C) 58,116 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LM10708, Expiry: 4/30/2015; Lot #: LM10859, Expiry: 5/31/2015; Lot #: LM11200, Expiry: 7/31/2015; Lot #: LM11679, Expiry: 9/30/2015; Lot #: LN10465, Expiry: 1/31/2016; Lot #: LN10750, Expiry: 3/31/2016; Lot #: LN11385, Expiry: 9/30/2016. B) Lot #: LM10709, Expiry: 4/30/2015; Lot #: LM10719, Expiry: 4/30/2015; Lot #: LM10721, Expiry: 4/30/2015; Lot #: LM10827, Expiry: 5/31/2015; Lot #: LM10828, Expiry: 5/31/2015; Lot #: LM10912, Expiry: 5/31/2015, Lot #: LM11205, Expiry: 7/31/2015; Lot #: LM11206, Expiry: 7/31/2015, Lot #: LM11239. Expiry: 7/31/2015; Lot #: LM11680, Expiry: 9/30/2015; Lot #: LM11822, Expiry: 10/31/2015; Lot #: LM11993, Expiry: 10/31/2015; Lot #: LN10114, Expiry: 12/31/2015; Lot #: LN10115, Expiry: 12/31/2015; Lot #: LN10695, Expiry: 3/31/2016; Lot #: LN10696, Expiry: 3/31/2016; Lot #: LN10697, Expiry: 3/31/2016; Lot #: LN10745, Expiry: 3/31/2016; Lot #: LN10749, Expiry: 3/31/2016; Lot #: LN11249, Expiry: 6/30/2016; Lot #: LN11374, Expiry: 8/31/2016; Lot #: LN11376, Expiry: 8/31/2016; Lot #: LN11382, Expiry: 7/31/2016; Lot #: LN11386, Expiry: 9/30/2016. C) Lot #: LM10685, Expiry: 4/30/2015; Lot #: LM10687, Expiry: 4/30/2015; Lot #: LM10691, Expiry: 4/30/2015; Lot #: LM10692, Expiry: 4/30/2015; Lot #: LM10707, Expiry: 4/30/2015; Lot #: LM10735, Expiry: 4/30/2015; Lot #: LM10741, Expiry: 4/30/2015; Lot #: LM10743, Expiry: 4/30/2015; Lot #: LM10860, Expiry: 5/31/2015; Lot #: LM10861, Expiry: 5/31/2015; Lot #: LM10862, Expiry: 5/31/2015; Lot #: LM10869, Expiry: 5/31/2015; Lot #: LM10911, Expiry: 5/31/2015; Lot #: LM11158, Expiry: 4/30/2015; Lot #: LM12039, Expiry: 10/31/2015; Lot #: LN10426, Expiry: 1/31/2016; Lot #: LN10427, Expiry: 1/31/2016; Lot #: LN10428, Expiry: 1/31/2016; Lot #: LN10435, Expiry: 1/31/2016; Lot #: LN10463, Expiry: 1/31/2016; Lot #: LN10464, Expiry: 1/31/2016; Lot #: LN10674, Expiry: 3/31/2016; Lot #: LN10675, Expiry: 3/31/2016; Lot #: LN10676, Expiry: 3/31/2016; Lot #: LN10751, Expiry: 3/31/2016; Lot #: LN11017, Expiry: 5/31/2016; Lot #: LN11018, Expiry: 5/31/2016; Lot #: LN11023, Expiry: 5/31/2016; Lot #: LN11216, Expiry: 6/30/2016; Lot #: LN11217, Expiry: 6/30/2016; Lot #: LN11391, Expiry: 9/30/2016; Lot #: LN11394, Expiry: 9/30/2016; Lot #: LN11401, Expiry: 9/30/2016; Lot #: LN11408, Expiry: 9/30/2016; Lot #: LN11410, Expiry: 9/30/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 24 of 35

Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.

D-1266-2015
Recall number
D-1266-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
539 Drums

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LN11320, Expiry: 7/31/2015; Lot #: LN11341, Expiry: 8/31/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 25 of 35

Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.

D-1267-2015
Recall number
D-1267-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
1,002 Drums

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LM10826, Expiry: 5/31/2015; Lot #: LM10999, Expiry: 5/31/2015; Lot #: LM11016, Expiry: 6/30/2015; Lot #: LM11032, Expiry: 6/30/2015; Lot #: LM11038, Expiry: 6/30/2015; Lot #: LM11087, Expiry: 6/30/2015; Lot #: LM11149, Expiry: 4/30/2015; Lot #: LM11156, Expiry: 4/30/2015; Lot #: LM11615, Expiry: 8/31/2015; Lot #: LN10195, Expiry: 12/31/2015; Lot #: LN10323, Expiry: 12/31/2015; Lot #: LN10500, Expiry: 1/31/2016; Lot #: LN10507, Expiry: 1/31/2016; Lot #: LN10514, Expiry: 2/29/2016; Lot #: LN10555, Expiry: 2/29/2016; Lot #: LN10556, Expiry: 2/29/2016; Lot #: LN10565, Expiry: 2/29/2016; Lot #: LN10784, Expiry: 3/31/2016; Lot #: LN10788, Expiry: 3/31/2016; Lot #: LN10831, Expiry: 3/31/2016; Lot #: LN10839, Expiry: 3/31/2016; Lot #: LN10846, Expiry: 3/31/2016; Lot #: LN10856, Expiry: 3/31/2016; Lot #: LN10884, Expiry: 3/31/2016; Lot #: LN10916, Expiry: 4/30/2016; Lot #: LN10931, Expiry: 4/30/2016; Lot #: LN10934, Expiry: 4/30/2016; Lot #: LN11067, Expiry: 5/31/2016; Lot #: LN11072, Expiry: 5/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 26 of 35

Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.

D-1268-2015
Recall number
D-1268-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
16,276 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LN11008, Expiry: 4/30/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 27 of 35

Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1269-2015
Recall number
D-1269-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LN10933, Expiry: 4/30/2015; Lot #: LN10935, Expiry: 4/30/2015; Lot #: LN11063, Expiry: 4/30/2015. B) Lot #: LN10987, Expiry: 4/30/2015; Lot #: LN11415, Expiry: 6/30/2015. C) Lot #: LN10986, Expiry: 4/30/2015; Lot #: LN11414, Expiry: 6/30/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 28 of 35

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC, 20 Waterview Blvd. Parsippany, NJ 07054 USA .

D-1270-2015
Recall number
D-1270-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 77,967 Bottles, B) 26,785 Bottles, and C) 5,463 Cartons.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LN11010, Expiry: 4/30/2015; Lot #: LN11011, Expiry: 4/30/2015; Lot #: LN11135, Expiry: 5/31/2015; Lot #: LN11136, Expiry: 5/31/2015; Lot #: LN11137, Expiry: 5/31/2015; Lot #: LN11138, Expiry: 5/31/2015; Lot #: LN11242, Expiry: 6/30/2015; Lot #: LN11243, Expiry: 6/30/2015. B) Lot #: LN11033, Expiry: 4/30/2015; Lot #: LN11034, Expiry: 4/30/2015; Lot #: LN11157, Expiry: 5/31/2015; Lot #: LN11158, Expiry: 5/31/2015; Lot #: LN11159, Expiry: 5/31/2015; Lot #: LN11160, Expiry: 5/31/2015; Lot #: LN11218, Expiry: 5/31/2015; Lot #: LN11219, Expiry: 5/31/2015; Lot #: LN11220, Expiry: 5/31/2015; Lot #: LN11222, Expiry: 6/30/2015; Lot #: LN11403, Expiry: 6/30/2015; Lot #: LN11413, Expiry: 8/31/2015; Lot #: LN11417, Expiry: 8/31/2015; Lot #: LN11418, Expiry: 8/31/2015. C) Lot #: LN10996, Expiry: 4/30/2015; Lot #: LN11172, Expiry: 5/31/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 29 of 35

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1271-2015
Recall number
D-1271-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 136,839 Bottles, B) 37,184 Bottles, C) 309 Pouches, and D) 9,764 Cartons.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LN10967, Expiry: 4/30/2015; Lot #: LN10968, Expiry: 4/30/2015; Lot #: LN10969, Expiry: 4/30/2015; Lot #: LN11076, Expiry: 4/30/2015; Lot #: LN11077, Expiry: 4/30/2015; Lot #: LN11078, Expiry: 4/30/2015; Lot #: LN11126, Expiry: 5/31/2015; Lot #: LN11127, Expiry: 5/31/2015; Lot #: LN11326, Expiry: 6/30/2015; Lot #: LN11330, Expiry: 6/30/2015; Lot #: LN11331, Expiry: 6/30/2015; Lot #: LN11335, Expiry: 7/31/2015. B) Lot #: LN11093, Expiry: 4/30/2015; Lot #: LN11094, Expiry: 4/30/2015; Lot #: LN11095, Expiry: 4/30/2015; Lot #: LN11096, Expiry: 4/30/2015; Lot #: LN11097, Expiry: 4/30/2015; Lot #: LN11101, Expiry: 5/31/2015; Lot #: LN11102, Expiry: 5/31/2015; Lot #: LN11103, Expiry: 5/31/2015; Lot #: LN11107, Expiry: 5/31/2015; Lot #: LN11108, Expiry: 5/31/2015; Lot #: LN11131, Expiry: 5/31/2015; Lot #: LN11132, Expiry: 5/31/2015; Lot #: LN11133, Expiry: 5/31/2015; Lot #: LN11203, Expiry: 5/31/2015; Lot #: LN11204, Expiry: 5/31/2015; Lot #: LN11325, Expiry: 6/30/2015. C) Lot #: LN10988, Expiry: 4/30/2015. D) Lot #: LN11192, Expiry: 5/31/2015; Lot #: LN11197, Expiry: 5/31/2015; Lot #:LN11198, Expiry: 5/31/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 30 of 35

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0734-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1272-2015
Recall number
D-1272-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 132,409 Bottles, B) 41,257 Bottles, C) 576 Pouches, and D) 6,429 Cartons.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LN11050, Expiry: 4/30/2015; Lot #: LN11053, Expiry: 4/30/2015; Lot #: LN11169, Expiry: 5/31/2015; Lot #: LN11312, Expiry: 6/30/2015; Lot #: LN11313, Expiry: 6/30/2015; Lot #: LN11318, Expiry: 6/30/2015. B) Lot #: LN11030, Expiry: 4/30/2015; Lot #: LN11031, Expiry: 4/30/2015; Lot #: LN11032, Expiry: 4/30/2015; Lot #: LN11038, Expiry: 4/30/2015; Lot #: LN11042, Expiry; 4/30/2015; Lot #: LN11047, Expiry: 4/30/2015; Lot #: LN11173, Expiry: 5/31/2015; Lot #: LN11289, Expiry: 6/30/2015; Lot #: LN11293, Expiry: 6/30/2015. C) Lot #: LN11185, Expiry: 5/31/2015; Lot #: LN11190, Expiry: 5/31/2015. D) Lot #: LN11180, Expiry: 5/31/2015.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 31 of 35

Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01.

D-1273-2015
Recall number
D-1273-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
84,542 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LM10769, Expiry: 4/30/2015; Lot #: LM10770, Expiry: 4/30/2015; Lot #: LM10771, Expiry: 4/30/2015; Lot #: LM10875, Expiry: 5/31/2015; Lot #: LM10876, Expiry: 5/31/2015; Lot #: LM11145, Expiry: 6/30/2015; Lot #: LM11174, Expiry: 6/30/2015; Lot #: LM11175, Expiry: 6/30/2015; Lot #: LM11226, Expiry: 7/31/2015; Lot #: LM11227, Expiry: 7/31/2015; Lot #: LM11289, Expiry: 7/31/2015; Lot #: LM11290, Expiry: 7/31/2015; Lot #: LM11544, Expiry: 8/31/2015; Lot #: LM11545, Expiry: 8/31/2015; Lot #: LM11671, Expiry: 9/30/2015; Lot #: LM11947, Expiry: 10/31/2015; Lot #: LM11948, Expiry: 10/31/2015; Lot #: LM11949, Expiry: 10/31/2015; Lot #: LM11950, Expiry: 10/31/2015; Lot #: LN10208, Expiry: 12/31/2015; Lot #: LN10209, Expiry: 12/31/2015; Lot #: LN10210, Expiry: 12/31/2015; Lot #: LN10211, Expiry: 12/31/2015; Lot #: LN10212, Expiry: 12/31/2015; Lot #: LN10213, Expiry: 12/31/2015; Lot #: LN10354, Expiry: 1/31/2016; Lot #: LN10355, Expiry: 1/31/2016; Lot #: LN10526, Expiry: 2/29/2016; Lot #: LN10527, Expiry: 2/29/2016; Lot #: LN10528, Expiry: 2/29/2016; Lot #: LN10529, Expiry: 2/29/2016; Lot #: LN10541, Expiry: 2/29/2016; Lot #: LN10840, Expiry: 4/30/2016; Lot #: LN11113, Expiry: 5/31/2016; Lot #: LN11333, Expiry: 7/31/2016; Lot #: LN11377, Expiry: 8/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 32 of 35

Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01.

D-1274-2015
Recall number
D-1274-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
68,066 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LM10763, Expiry: 4/30/2015; Lot #: LM10764, Expiry: 4/30/2015; Lot #: LM10765, Expiry: 4/30/2015; Lot #: LM11142, Expiry: 6/30/2015; Lot #: LM11143, Expiry: 6/30/2015; Lot #: LM11144, Expiry: 6/30/2015; Lot #: LM11255, Expiry: 7/31/2015; Lot #: LM11256, Expiry: 7/31/2015; Lot #: LM11265, Expiry: 7/31/2015; Lot #: LM11542, Expiry: 8/31/2015; Lot #: LM11543, Expiry: 8/31/2015; Lot #: LN10197, Expiry: 12/31/2015; Lot #: LN10198, Expiry: 12/31/2015; Lot #: LN10199, Expiry: 12/31/2015; Lot #: LN10200, Expiry: 12/31/2015; Lot #: LN10202, Expiry: 12/31/2015; Lot #: LN10203, Expiry: 12/31/2015; Lot #: LN10395, Expiry: 1/31/2016; Lot #: LN10396, Expiry: 1/31/2016; Lot #: LN10531, Expiry: 2/29/2016; Lot #: LN10532, Expiry: 2/29/2016; Lot #: LN10533, Expiry: 2/29/2016; Lot #: LN10534, Expiry: 2/29/2016; Lot #: LN10796, Expiry: 2/29/2016; Lot #: LN10942, Expiry: 4/30/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 33 of 35

Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1275-2015
Recall number
D-1275-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 162,743 Bottles and B) 14,205 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LM10843, Expiry: 5/31/2015; Lot #: LM11331, Expiry: 7/31/2015; Lot #: LM11332, Expiry: 7/31/2015; Lot #: LM11376, Expiry: 7/31/2015; Lot #: LM11583, Expiry: 8/31/2015; Lot #: LM11987, Expiry: 11/30/2015; Lot #: LN10065, Expiry: 12/31/2015; Lot #: LN10066, Expiry: 12/31/2015; Lot #: LN10334, Expiry: 1/31/2016; Lot #: LN10335, Expiry: 1/31/2016; Lot #: LN10443, Expiry: 1/31/2016; Lot #: LN10879, Expiry: 4/30/2016; Lot #: LN10971, Expiry: 4/30/2016; Lot #: LN11178, Expiry: 6/30/2016; Lot #: LN11184, Expiry: 6/30/2016; Lot #: LN11348, Expiry: 7/31/2016. B) Lot #: LM10683, Expiry: 4/30/2015; Lot #: LM10842, Expiry: 5/31/2015; Lot #: LM11377, Expiry: 7/31/2015; Lot #: LM11584, Expiry: 8/31/2015; Lot #: LM11985, Expiry: 11/30/2015; Lot #: LM11988, Expiry: 11/30/2015; Lot #: LN10064, Expiry: 12/31/2015; Lot #: LN10336, Expiry: 1/31/2016; Lot #: LN10446, Expiry: 1/31/2016; Lot #: LN10880, Expiry: 4/30/2016; Lot #: LN10883, Expiry: 4/30/2016; Lot #: LN10972, Expiry: 4/30/2016; Lot #: LN11177, Expiry: 6/30/2016; Lot #: LN11256, Expiry: 7/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 34 of 35

Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

D-1276-2015
Recall number
D-1276-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
A) 216,329 Bottles and B) 18,514 Bottles.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

A) Lot #: LM11093, Expiry: 6/30/2015; Lot #: LM11335, Expiry: 7/31/2015; Lot #: LM11336, Expiry: 7/31/2015; Lot #: LM11461, Expiry: 8/31/2015; Lot #: LM11462, Expiry: 8/31/2015; Lot #: LM11579, Expiry: 8/31/2015; Lot #: LM11778, Expiry: 9/30/2015; Lot #: LM11995, Expiry: 11/30/2015; Lot #: LN10029, Expiry: 11/30/2015; Lot #: LN10071, Expiry: 12/31/2015; Lot #: LN10349, Expiry: 1/31/2016; Lot #: LN10350, Expiry: 1/31/2016; Lot #: LN10505, Expiry: 2/29/2016; Lot #: LN10506, Expiry: 2/29/2016; Lot #: LN10814, Expiry: 3/31/2016; Lot #: LN10815, Expiry: 3/31/2016; Lot #: LN10977, Expiry: 4/30/2016; Lot #: LN11156, Expiry: 6/30/2016; Lot #: LN11260, Expiry: 7/31/2016. B) Lot #: LM10643, Expiry: 4/30/2015; Lot #: LM10846, Expiry: 5/31/2015; Lot #: LM11347, Expiry: 7/31/2015; Lot #: LM11492, Expiry: 8/31/2015; Lot #: LM11493, Expiry: 8/31/2015; Lot #: LM11577, Expiry: 8/31/2015; Lot #: LM11732, Expiry: 9/30/2015; Lot #: LM11994, Expiry: 11/30/2015; Lot #: LN10072, Expiry: 12/31/2015; Lot #: LN10073, Expiry: 12/31/2015; Lot #: LN10351, Expiry: 1/31/2016; Lot #: LN10561, Expiry: 2/29/2016; Lot #: LN10562, Expiry: 2/29/2016; Lot #: LN10816, Expiry: 3/31/2016; Lot #: LN10817, Expiry: 4/30/2016; Lot #: LN11162, Expiry: 6/30/2016; Lot #: LN11170, Expiry: 6/30/2016; Lot #: LN11171, Expiry: 6/30/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.

drug · product 35 of 35

Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01.

D-1277-2015
Recall number
D-1277-2015
Initiated
April 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Wockhardt Usa Inc.
Quantity
68,969 Bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information

Lot #: LM11354, Expiry: 7/31/2015; Lot #: LM11355, Expiry: 7/31/2015; Lot #: LM11374, Expiry: 7/31/2015; Lot #: LM11626, Expiry: 8/31/2015; Lot #: LM12004, Expiry: 11/30/2015; Lot #: LM12005, Expiry: 11/30/2015; Lot #: LN10080, Expiry: 10/31/2015; Lot #: LN10393, Expiry: 1/31/2016; Lot #: LN10447, Expiry: 1/31/2016; Lot #: LN10736, Expiry: 2/29/2016; Lot #: LN11316, Expiry: 7/31/2016.

Distribution pattern

U.S. Nationwide including Puerto Rico.