• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of August 13, 2014

  • Print
  • Share
  • E-mail

Product Detail

Product Description 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.
Recall Number D-1511-2014
Classification Class II
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
Product Distributed Qty a) 43,585 bottles; b) 296,968 bottles
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.

Event Detail

Event Id 68786
Product Type Drugs
Status Ongoing
Recalling Firm Caraco Pharmaceutical Laboratories, Ltd.
City Detroit
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-06-26
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Puerto Rico