FDA recall D-0599-2021

Product

Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.

Reason for recall

Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-05-04

Report date

2021-06-02

Termination date

2023-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2021