FDA-Drug2018-06-27Class II

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

Dr. Reddy's Laboratories, Inc.
Hazard

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

Sold states
Nationwide in the USA
Affected count
6,397 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0878-2018

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