Reported Aug 13, 2014 · Terminated

Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC…

Caraco Pharmaceutical Laboratories, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Caraco Pharmaceutical Laboratories, Ltd. · 1150 Elijah McCoy Dr · Detroit, MI · 48202-3344

Is this the product you have?

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 bySun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India

Lot codes and dates: 209 of 209 codes
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
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
Amount recalled: a) 43,585 bottles; b) 296,968 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88)…

Where it was sold

Nationwide
PR

Why it was recalled

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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