US Drug Recall Register
Class III · Low risk Terminated Initiated Jan 29, 2018 (9 years ago)

Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

What was recalled

Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
55111-122-05
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0419-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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