PlainRecalls
FDA Drug Moderate Class II Terminated

Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.

Reported: August 8, 2018 Initiated: June 28, 2018 #D-1023-2018

Product Description

Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.

Reason for Recall

Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.

Details

Recalling Firm
PFIZER
Units Affected
234,680 vials
Distribution
Nationwide in the USA and Puerto Rico.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.. Recalled by PFIZER. Units affected: 234,680 vials.
Why was this product recalled?
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 8, 2018. Severity: Moderate. Recall number: D-1023-2018.