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FDAFDA · Food and drugs·Recall number D-1604-2014

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

Published October 1, 2014 · Recall initiated: September 9, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.

What to do

Voluntary: Firm initiated

Recall details

Brand
BUPRENORPHINE HYDROCHLORIDE
Manufacturer
Hospira Inc.
Distributor
Nationwide
Lot
Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015
Risk classification
Class II
Area (FDA)
drug
Country
United States

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