FDA recall D-0222-2018

AVKARE Inc. · Class II · drug

Product

Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.

Reason for recall

Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2018-01-03
Report date
2018-01-24
Termination date
2020-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2018