Drug recall D-1604-2014

Class II Terminated reported Oct 1, 2014

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Hospira Inc., Lake Forest, IL
Quantity
373,180 Carpuject units
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
September 9, 2014
Terminated
March 17, 2017

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