Nalbuphine HCl Injection recall: Sterility Concern
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Why was Nalbuphine HCl Injection recalled?
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 #: 11-293-DK, Exp 05/01/13
- Product
- Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
- Recalling firm
- Hospira, Inc.
- Quantity
- 145,400 vials
- Distribution
- Nationwide and Puerto Rico.
- Recall date
- December 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)