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
Reported: July 3, 2024 Initiated: May 20, 2024 #D-0564-2024
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.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 84,710 cartridges
- Distribution
- US Nationwide and Puerto Rico.
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pfizer Inc.. Units affected: 84,710 cartridges.
Why was this product recalled? ▼
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 3, 2024. Severity: Moderate. Recall number: D-0564-2024.
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