FDAClass IIIJune 2, 2021

Atorvastatin Calcium Tablets recall: Impurity Out of Spec

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

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 # C905063, Exp 07/2021

Product
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
2980 500 count -bottles
Distribution
Distributed Nationwide in the USA
Recall date
June 2, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls