Buprenorphine Hydrochloride Injection recall: Sterility Concern
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
Why was Buprenorphine Hydrochloride Injection recalled?
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10
- 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
- Recalling firm
- Pfizer Inc.
- Quantity
- 84,710 cartridges
- Distribution
- US Nationwide and Puerto Rico.
- Recall date
- July 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)