Status
Ongoing
Drug Enforcement D-0564-2024
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Classification
Class II
Report Date
July 3, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 84,710 cartridges
- Reason for recall
- Lack of Assurance of Sterility-The potential for incomplete crimp seals.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Pfizer Inc.
- Address
-
235 East 42nd Street
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0564-2024
- Event ID
- 94681
- Recall initiation date
- May 20, 2024
- Center classification date
- June 22, 2024
- Code info
- Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10
- More code info
- —