FDA recall D-1329-2015

Mylan Institutional LLC · Class I · drug

Product

Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.

Reason for recall

Presence of Particulate Matter

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-04-23
Report date
2015-08-19
Termination date
2016-06-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1329-2015