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.
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 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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