FDA recall D-0726-2022

Product

Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90

Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification results for related substance.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2022-03-16

Report date

2022-04-06

Termination date

2023-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0726-2022