Recalls / Class II
Class IID-137-2013
Product
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.
- Affected lot / code info
- Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
Why it was recalled
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 11,580 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2013-01-16
- FDA classified
- 2013-01-28
- Posted by FDA
- 2013-02-06
- Terminated
- 2013-12-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-137-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.