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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76664

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

Open FDA event record

Event summary

Timeline bucket
March 07, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Alvogen, 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

9 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 9

Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.

D-0627-2017
Recall number
D-0627-2017
Initiated
March 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information

Lot #: BXH1P22, BXH1P21A, BXH1P21, BXH1P31, BXH1P21B, Exp. 11/2017; BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, BXH6ER1, Exp. 06/2018; BXH81K1A, BXHBJD1A, Exp. 10/2018

Distribution pattern

Nationwide

drug · product 2 of 9

Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05

D-0628-2017
Recall number
D-0628-2017
Initiated
March 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information

Lot #: BXH1P21A, Exp. 11/2017

Distribution pattern

Nationwide

drug · product 3 of 9

Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05

D-0629-2017
Recall number
D-0629-2017
Initiated
March 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information

Lot #: BXH1BE1A, BXH1P41A, Exp. 01/2018.

Distribution pattern

Nationwide

drug · product 4 of 9

Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.

D-0630-2017
Recall number
D-0630-2017
Initiated
March 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information

Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019.

Distribution pattern

Nationwide

drug · product 5 of 9

Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.

D-0631-2017
Recall number
D-0631-2017
Initiated
March 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information

Lot #: BXH1P51, BXH66D1, BXH1P51A, BXH5ZS1, Exp. 03/2018; BXH1P52, Exp. 05/2018; BXHBKF1A, and BXHB8S1A, Exp. 10/2018.

Distribution pattern

Nationwide

drug · product 6 of 9

Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305

D-0632-2017
Recall number
D-0632-2017
Initiated
March 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information

Lot #: BXH66D1A, Exp. 03/2018

Distribution pattern

Nationwide

drug · product 7 of 9

Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401

D-0633-2017
Recall number
D-0633-2017
Initiated
March 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information

Lot #: BXHBJD1A, Exp. 10/2018

Distribution pattern

Nationwide

drug · product 8 of 9

Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501

D-0634-2017
Recall number
D-0634-2017
Initiated
March 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information

Lot #: BXCUE1A, Exp. 01/2019

Distribution pattern

Nationwide

drug · product 9 of 9

Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601

D-0635-2017
Recall number
D-0635-2017
Initiated
March 07, 2017
Classification
Class III
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information

Lot #: BXHD7U1A, Exp. 10/2018

Distribution pattern

Nationwide