Recalls / Class II
Class IID-1511-2014
Product
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.
- Affected lot / code info
- 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
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.
Recalling firm
- Firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1150 Elijah McCoy Dr, N/A, Detroit, Michigan 48202-3344
Distribution
- Quantity
- a) 43,585 bottles; b) 296,968 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-06-26
- FDA classified
- 2014-08-01
- Posted by FDA
- 2014-08-13
- Terminated
- 2015-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1511-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.