FDA recall D-0778-2017

Key Pharmacy and Compounding Center · Class II · drug

Product

SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Pharmacy

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Distribution

Distributed nationwide in U.S.A., Australia and Canada.

Key facts

Status
Terminated
Initiation date
2017-04-18
Report date
2017-05-24
Termination date
2017-08-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Federal Way, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0778-2017