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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68786

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

Open FDA event record

Event summary

Timeline bucket
June 26, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Caraco Pharmaceutical Laboratories, Ltd.

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

2 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 2

Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.

D-1510-2014
Recall number
D-1510-2014
Initiated
June 26, 2014
Classification
Class II
Status
Terminated
Quantity
a) 70,152 bottles; b) 43,525 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: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Code information

Lot #: a) AGL0098B, AGL0099B, AGL0100B, AGL0101B, Exp 09/14; AGM0073B, AGM0074B, Exp 04/15; AGM0125B, AGM0126B, Exp 07/15; AGM0158B, Exp 09/15; b) AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14; AGM0067A, AGM0068A, AGM0069A, Exp 03/15; AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15; AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A, AGM0132A, Exp 07/15

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 2

Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.

D-1511-2014
Recall number
D-1511-2014
Initiated
June 26, 2014
Classification
Class II
Status
Terminated
Quantity
a) 43,585 bottles; b) 296,968 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: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Code information

Lot #: a) AGL0058B, AGL0059B, AGL0060B, AGL0061B, Exp 06/14; AGL0062B, AGL0063B, AGL0064B, Exp 07/14; AGL0083B, AGL0084B, AGL0085B, AGL0086B, AGL0087B, AGL0088B, AGL0089B, AGL0090B, Exp 08/14; AGL0120B, AGL0121B, AGL0122B, AGL0123B, Exp 11/14; AGM0001B, AGM0002B, AGM0003B, AGM0004B, Exp 12/14; AGM0021B, AGM0022B, AGM0023B, AGM0024B, Exp 01/15; AGM0031B, AGM0032B, AGM0033B, AGM0034B, Exp 02/15; AGM0053B, AGM0054B, AGM0055B, AGM0056B, Exp 03/15; AGM0075B, AGM0076B, AGM0077B, AGM0078B, Exp 04/15; AGM0091B, AGM0092B, AGM0093B, AGM0094B, Exp 05/15; AGM0118B, AGM0119B, AGM0120B, AGM0121B, Exp 07/15; AGM0138B, AGM0144B, AGM0145B, AGM0146B, Exp 08/15; AGM0164B, AGM0165B, AGM0166B, Exp 09/15; b) AGL0065A, AGL0066A, AGL0067A, AGL0068A, AGL0069A, AGL0070A, AGL0071A, AGL0072A, AGL0073A, AGL0074A, AGL0075A, AGL0076A, Exp 07/14; AGL0077A, AGL0078A, AGL0079A, AGL0080A, AGL0081A, AGL0082A, AGL0091A, Exp 08/14; AGL0106A, AGL0107A, AGL0108A, AGL0109A, AGL0110A, AGL0111A, Exp 09/14; AGL0113A, AGL0114A, AGL0115A, AGL0116A, AGL0117A, AGL0118A, AGL0119A, Exp 10/14; AGL0124A, AGL0125A, AGL0126A, AGL0127A, AGL0128A, AGL0129A, AGL0130A, AGL0131A, AGL0132A, AGL0133A, AGL0134A, Exp 11/14; AGM0005A, AGM0006A, AGM0007A, AGM0008A, AGM0009A, AGM0010A, AGM0011A, AGM0012A, AGM0013A, AGM0014A, AGM0015A, AGM0016A, Exp 12/14; AGM0017A, AGM0018A, AGM0019A, AGM0020A, AGM0025A, AGM0026A, AGM0027A, AGM0028A, AGM0029A, AGM0030A, Exp 01/15; AGM0035A, AGM0036A, AGM0037A, AGM0038A, AGM0039A, AGM0040A, AGM0041A, AGM0042A, AGM0043A, AGM0044A, AGM0045A, AGM0046A, AGM0047A, AGM0048A, Exp 02/15; AGM0049A, AGM0050A, AGM0051A, AGM0052A, AGM0057A, AGM0058A, AGM0059A, AGM0060A, AGM0061A, AGM0062A, AGM0063A, AGM0064A, AGM0065A, AGM0066A, Exp 03/15; AGM0079A, AGM0080A, AGM0081A, AGM0082A, AGM0083A, AGM0084A, Exp 04/15; AGM0087A, AGM0088A, AGM0089A, AGM0090A, AGM0095A, AGM0096A, AGM0097A, AGM0098A, AGM0099A, Exp 05/15; AGM0100A, AGM0101A, AGM0102A, AGM0103A, AGM0104A, AGM0105A, AGM0106A, AGM0107A, AGM0108A, AGM0109A, AGM0110A, AGM0111A, AGM0112A, AGM0113A, AGM0114A, AGM0115A, AGM0116A, AGM0117A, AGM0122A, AGM0123A, AGM0124A, AGM0133A, AGM0134A, Exp Date: 2015-07-31; Lot # AGM0135A, Exp Date: 2015-07-31; Lot # AGM0136A, Exp 07/15; AGM0137A, AGM0139A, AGM0140A, AGM0141A, AGM0142A, AGM0143A, AGM0147A, AGM0148A, AGM0149A, AGM0150A, AGM0151A, AGM0152A, AGM0153A, AGM0154A, AGM0155A, AGM0156A, AGM0157A, Exp 08/15; AGM0167A, AGM0168A, Exp 09/15

Distribution pattern

Nationwide and Puerto Rico