FDA-Drug2017-08-09Class III
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.
Dr. Reddy's Laboratories, Inc.
Hazard
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Sold states
Nationwide in the USA
Affected count
544 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1038-2017Don't want to check this manually?
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