Home / Recalls / Dr. Reddy's Laboratories, Inc. / D-1079-2018

D-1079-2018 Class III Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
August 22, 2018
Initiation Date
August 2, 2018
Termination Date
April 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2280 bottles

Product Description

Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05

Reason for Recall

Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.

Distribution Pattern

U.S.A. Nationwide

Code Information

T60045

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