FDAClass IIDecember 11, 2013

Morphine Sulfate Injection recall: Sterility Concern

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…

Why was Morphine Sulfate Injection recalled?

Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.

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 #17368EV Exp 08/13

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…
Recalling firm
Hospira, Inc.
Quantity
29,700 vials
Distribution
Nationwide
Recall date
December 11, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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