January 2013 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-137-2013 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on January 16, 2013 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-137-2013

Reason for Recall
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Initiated
01-16-2013
Reported
02-06-2013
Quantity
11,580 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64154
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-05-2013
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14