FDAClass IIJune 20, 2012

Diazepam Injection recall: Impurity Out of Spec

Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian…

Why was Diazepam Injection recalled?

Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Meridian Medical Technologies a Pfizer Company
Quantity
83,400 autoinjectors
Distribution
Nationwide, military, Italy, Singapore, Sweden, and Canada.
Recall date
June 20, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls