FDA recall D-0722-2017

Product

HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial.

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-0722-2017