FDAClass IIMay 8, 2013

Preservative-Free MORPHINE Sulfate Injection recall: Sterility Concern

Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12

Why was Preservative-Free MORPHINE Sulfate Injection recalled?

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial

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 15-065-DK, Exp 1SEP2013

Product
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
Recalling firm
Hospira Inc.
Quantity
26,100 vials
Distribution
Nationwide and Puerto Rico
Recall date
May 8, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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