FDA-Drug2014-10-01Class II

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

Hospira Inc.
Hazard

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

Sold states
Nationwide
Affected count
373,180 Carpuject units
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1604-2014

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