FDA recall D-1194-2015

Lincare, Inc. · Class II · drug

Product

Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

Reason for recall

Lack of Assurance of Sterility: Sterility of product is not assure

Distribution

United States including: Arkansas

Key facts

Status: Terminated
Initiation date: 2015-05-28
Report date: 2015-07-08
Termination date: 2017-02-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1194-2015