Drug 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
D-1604-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69163
- Status
- Terminated
- Classification
- Class II
- Quantity
- 373,180 Carpuject units
- Official record key
drug-enforcement:D-1604-2014
Official wording
Reason: Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Code information: Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification