FDAClass IIIJune 23, 2021

Atorvastatin Calcium Tablets recall: Impurity Out of Spec

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…

Why was Atorvastatin Calcium Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: C905064, C905065, Exp. Date 07/2021

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…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
5984 bottles
Distribution
Nationwide within the United States
Recall date
June 23, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls