D-137-2013 Class II Terminated
FDA drug recall D-137-2013 was initiated by Mylan Pharmaceuticals Inc. on Jan 16, 2013 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness. The recall status is terminated (terminated Dec 5, 2013). Affected quantity: 11,580 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 6, 2013
- Initiation Date
- Jan 16, 2013
- Termination Date
- Dec 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,580 bottles
Product description
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.
Reason for recall
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Distribution pattern
Nationwide.
Code information
Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-137-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026