FDA recall D-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.

Reason for recall

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

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2013-01-16

Report date

2013-02-06

Termination date

2013-12-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

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