D-0564-2024 Class II Ongoing
FDA drug recall D-0564-2024 was initiated by Pfizer Inc. on May 20, 2024 and is designated Class II. Reason for recall: Lack of Assurance of Sterility-The potential for incomplete crimp seals. The recall status is ongoing. Affected quantity: 84,710 cartridges.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 3, 2024
- Initiation Date
- May 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84,710 cartridges
Product description
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 for recall
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Distribution pattern
US Nationwide and Puerto Rico.
Code information
Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0564-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026