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

Enforcement Report - Week of February 6, 2013

  • Print
  • Share
  • E-mail

Event Detail

Event ID 64154
Product Type Drugs
Status Ongoing
Recalling Firm Mylan Pharmaceuticals Inc.
City Morgantown
State WV
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-16
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3. Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14 Class II Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness. 11,580 bottles D-137-2013