FDA-Drug2013-02-06Class II

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.

Mylan Pharmaceuticals Inc.
Hazard

Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.

Sold states
Nationwide.
Affected count
11,580 bottles
Manufactured in
781 Chestnut Ridge Rd, Morgantown, WV, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-137-2013

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