FDA recall D-0610-2017

Product

Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13

Reason for recall

Failed impurities/ degradation specifications: Product was above specification for unknown impurities.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-02-15

Report date

2017-03-29

Termination date

2022-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0610-2017