July 2014 FDA Recall Drug by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) (D-1435-2014 - Failed Impurities/Degradation Specifications)

This Class III drug recall was voluntarily initiated by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) on July 3, 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-1435-2014

Reason for Recall
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Initiated
07-03-2014
Reported
07-23-2014
Quantity
1,184 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68787
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 Institutional, Inc. (d.b.a. UDL Laboratories)
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, Puerto Rico, and Guam.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-26-2016
Product Description About Product Description
Full technical description of the product.
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

Batch or Lot Expiration Information

Lot# : 3045659, 3048256, Exp 07/14