June 2014 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-1557-2014 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on June 19, 2014 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1557-2014

Reason for Recall
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Initiated
06-19-2014
Reported
09-03-2014
Quantity
2,658 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68645
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2015
Product Description About Product Description
Full technical description of the product.
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.

Batch or Lot Expiration Information

Lot# Lot 3040063 Exp. 07/14