FDA recall D-0629-2021

Product

Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's 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

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2021-06-04

Report date

2021-06-23

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-0629-2021