Recalls / Class II
Class IID-1604-2014
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
- Brand name
- Buprenorphine Hydrochloride
- Generic name
- Buprenorphine Hydrochloride
- Active ingredient
- Buprenorphine Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 0409-2012
- FDA application
- ANDA074137
- Affected lot / code info
- Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015
Why it was recalled
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 373,180 Carpuject units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-09-09
- FDA classified
- 2014-09-19
- Posted by FDA
- 2014-10-01
- Terminated
- 2017-03-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1604-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.