FDA Drug Class III — Least Serious

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.

Hazard

Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

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, Bach
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18

Units Affected

544 bottles