FDAClass IIJune 27, 2018

Atorvastatin Calcium Tablets recall: Foreign Material

Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC…

Why was Atorvastatin Calcium Tablets recalled?

Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.

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 #: T800064, Exp 12/2019

Product
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
6,397 bottles
Distribution
Nationwide in the USA
Recall date
June 27, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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