Hospira Recalls Nalbuphine Hydrochloride Injection Due to Sterility Concerns
Hospira is recalling 145,400 vials of Nalbuphine Hydrochloride Injection because loose crimps and missing stoppers prevent assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or hospitalization due to potential infection.
Plain-English summary
Hospira, Inc. is recalling 145,400 vials of Nalbuphine Hydrochloride Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial (NDC 0409-1467-01). The affected product is identified by Lot # 11-293-DK with an expiration date of 05/01/13. The recall was initiated due to complaints regarding a loose crimp applied to the fliptop vial, as well as reports of missing stoppers and flip caps. These defects mean that the sterility of the product cannot be assured.
The affected product was distributed nationwide and in Puerto Rico. Nalbuphine Hydrochloride is a prescription medication used for pain management, administered via intramuscular, intravenous, or subcutaneous routes. Because the sterility of the recalled vials cannot be guaranteed, there is a potential risk of infection if the product is used.
Healthcare providers and patients should stop using the affected lot immediately. Hospira, Inc. is the recalling firm responsible for managing the recall. Consumers and healthcare facilities should check their inventory for the specific lot number and expiration date listed above and contact Hospira or their local FDA office for further instructions on disposal or replacement.
The recalled product
- Product
- NALBUPHINE HYDROCHLORIDE (NALBUPHINE HYDROCHLORIDE)
- Brand
- NALBUPHINE HYDROCHLORIDE
- Manufacturer
- Hospira, Inc.
- Affected units
- 145,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 11-293-DK
- Exp 05/01/13
Distribution
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