PlainRecalls
FDA Drug Moderate Class II Terminated

Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900

Reported: June 27, 2018 Initiated: May 30, 2018 #D-0878-2018

Product Description

Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900

Reason for Recall

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

Details

Units Affected
6,397 bottles
Distribution
Nationwide in the USA
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 6,397 bottles.
Why was this product recalled?
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 27, 2018. Severity: Moderate. Recall number: D-0878-2018.