June 2012 FDA Recall Diazepam by Meridian Medical Technologies A Pfizer Company
D-1369-2012 - Impurities/Degradation Products

This Class II drug recall was voluntarily initiated by Meridian Medical Technologies A Pfizer Company on June 6, 2012 for the product Diazepam. The FDA reported the reason for recall as impurities/degradation products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1369-2012

Reason for Recall
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Initiated
06-06-2012
Reported
06-20-2012
Quantity
83,400 autoinjectors

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62015
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.
Meridian Medical Technologies a Pfizer Company
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, military, Italy, Singapore, Sweden, and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-05-2013
Product Description About Product Description
Full technical description of the product.
Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subsidiary of King Pharmaceuticals, Inc.; NSN 6505-01-274-0951, NDC 11704-600-01.

Batch or Lot Expiration Information

Lot# : 8D1082, Exp 01/13; 8D1151, Exp 03/13

Affected Packages Involved in this Recall

11704-600-01 Diazepam