Product: Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ  08540 USA.
Reason for recall: Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Recall initiated: 20170711
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated