FDA recall D-0661-2020

AVKARE Inc. · Class II · drug

Product

Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for related compounds.

Distribution

Nationwide in the USA.

Key facts

Status
Terminated
Initiation date
2020-01-07
Report date
2020-01-22
Termination date
2021-07-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0661-2020