Dr. Reddy's Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC
Recalled August 9, 2017 · FDA recall D-1038-2017 · Dr. Reddy's Laboratories
Hazard
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220. · FDA Class III
Units
544 bottles
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
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.
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →