Buprenorphine Hydrochloride Injection — Class II drug recall D-1604-2014
Terminated recall by Hospira Inc., reported 2014-10-01, distributed nationwide. Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at
| Recall number | D-1604-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-09-09 |
| Classified | 2014-09-19 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2017-03-17 |
| Distributed | Nationwide (US) |
| Quantity | 373,180 carpuject |
| Reason classes | specification failure |
| NDC | 00409-2012, 00409-2012-03, 00409-2012-32 |
| Lot numbers | 35-730-LL, 35-745-LL |
| Expiration dates | 2015-02-01 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1604-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.