FDA recall D-0123-2018

Pfizer Inc. · Class I · drug

Product

Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02

Reason for recall

Presence of Particulate Matter: glass particulate found in vial

Distribution

Nationwide USA and Puerto Rico

Key facts

Status
Terminated
Initiation date
2017-08-30
Report date
2017-12-27
Termination date
2018-11-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0123-2018