May 2021 FDA Recall Atorvastatin Calcium by Dr. Reddy's Laboratories, Inc.
D-0599-2021 - Failed Impurities -Degradation Specifications
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on May 4, 2021 for the product Atorvastatin Calcium. The FDA reported the reason for recall as failed impurities -degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0599-2021
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
05-04-2021
06-02-2021
2980 500 count -bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA
02-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# C905063, Exp 07/2021
