The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-023-2014·Announced 2013-12-11

Hospira Recalls Morphine Sulfate Injection Due to Vial Leakage

Hospira is recalling 29,700 vials of Morphine Sulfate Injection because a confirmed report indicated vial neck breakage caused leakage, compromising 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 involves a confirmed defect (vial neck breakage) that compromises sterility, which aligns with the rubric criteria for Severe severity involving significant injury or property damage reports or high-risk defects.

Plain-English summary

Hospira, Inc. is recalling 29,700 vials of Morphine Sulfate Injection, USP (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial. The product is identified by Lot #17368EV with an expiration date of 08/13 and NDC 0409-1135-02. The recall was initiated due to a lack of assurance of sterility.

The recall was triggered by a confirmed customer report of leakage of vial contents resulting from the breaking of the vial neck. This defect poses a risk to the sterility of the medication. The affected product was distributed nationwide.

Healthcare providers and patients should stop using the affected vials and contact Hospira, Inc. for further instructions or replacement. The recall is classified as FDA Class II.

The recalled product

Product
Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.
Manufacturer
Hospira, Inc.
Category
Drug — Injection
Hazard
Affected units
29,700

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 (1)

  • Lot #17368EV Exp 08/13

Distribution

Distributed nationwide across the United States.

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