Drug Enforcement D-137-2013

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

Status

Terminated

Classification

Class II

Report Date

February 6, 2013

Termination Date

December 5, 2013

Product Information

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.
Product quantity
11,580 bottles
Reason for recall
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide.

Location & Firm

Recalling firm
Mylan Pharmaceuticals Inc.
Address
781 Chestnut Ridge Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-137-2013
Event ID
64154
Recall initiation date
January 16, 2013
Center classification date
January 28, 2013
Code info
Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
More code info
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