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.
Reported: February 6, 2013 Initiated: January 16, 2013 #D-137-2013
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.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 11,580 bottles
- Distribution
- Nationwide.
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 11,580 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 6, 2013. Severity: Moderate. Recall number: D-137-2013.
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