PlainRecalls
FDA Drug Low Class III Terminated

Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

Reported: February 7, 2018 Initiated: January 29, 2018 #D-0420-2018

Product Description

Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

Reason for Recall

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

Details

Units Affected
12,579 bottles
Distribution
Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 12,579 bottles.
Why was this product recalled?
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2018. Severity: Low. Recall number: D-0420-2018.