FDA recall D-1515-2019

Product

Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ

Reason for recall

Failed Dissolution Specifications

Distribution

Product was shipped to wholesalers throughout the United States.

Key facts

Status

Terminated

Initiation date

2019-07-19

Report date

2019-07-31

Termination date

2021-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1515-2019