September 2014 FDA Recall Buprenorphine Hydrochloride by Hospira Inc.
D-1604-2014 - Failed Impurities/Degradation Specification

This Class II drug recall was voluntarily initiated by Hospira Inc. on September 9, 2014 for the product Buprenorphine Hydrochloride. The FDA reported the reason for recall as failed impurities/degradation specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1604-2014

Reason for Recall
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Initiated
09-09-2014
Reported
10-01-2014
Quantity
373,180 Carpuject units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69163
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.
Hospira 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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-17-2017
Product Description About Product Description
Full technical description of the product.
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32

Batch or Lot Expiration Information

Lot# Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015

Affected Packages Involved in this Recall

0409-2012-03 Buprenorphine Hydrochloride
0409-2012-32 Buprenorphine Hydrochloride