The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-096-2013·Announced 2012-12-26

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category
Drug — Injectable Prescription Drug
Hazard
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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