PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 8, 2013 Initiated: August 28, 2012 #D-308-2013

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Hospira Inc.
Units Affected
26,100 vials
Distribution
Nationwide and Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira Inc.. Units affected: 26,100 vials.
Why was this product recalled?
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Which agency issued this recall?
This recall was issued by the FDA Drug on May 8, 2013. Severity: Moderate. Recall number: D-308-2013.