Recall: D-0418-2018

Class III - Minor Violations

Class IIIClassification

2018-01-29Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05

Reason

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.