FDA Drug recall D-0564-2024
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular…
- FDA Drug
- Class II
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular… by Pfizer, citing lack of Assurance of Sterility-The potential for incomplete crimp seals.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0564-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-20 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03
Reason
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Identifiers
| ndc | 0409-2012-03 |
|---|---|
| ndc | 0409-2012-32 |
| code_info | Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0564-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.