Caraco Pharmaceutical Laboratories Cephalexin Capsules 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.

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.

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

Nationwide and Puerto Rico

• Compare the lot number and expiration date on your package with the codes above.
• Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
• If you have symptoms you think are related, contact your doctor. In an emergency call 911.
• Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall number

D-1511-2014

Classification

Class II

Status

Terminated

Recall initiated

Jun 26, 2014

FDA report date

Aug 13, 2014

Quantity

a) 43,585 bottles; b) 296,968 bottles

Recall type

Voluntary: Firm initiated

Recalling firm

Caraco Pharmaceutical Laboratories, Ltd.