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
Reported: October 1, 2014 Initiated: September 9, 2014 #D-1604-2014
Product Description
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.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 373,180 Carpuject units
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hospira Inc.. Units affected: 373,180 Carpuject units.
Why was this product recalled? ▼
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 1, 2014. Severity: Moderate. Recall number: D-1604-2014.
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