Drug recall D-1038-2017
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.
Lots and codes
Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 544 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 11, 2017
- Terminated
- April 1, 2019
Related products
- Pravastatin Sodium – drug information
- NDC 55111-230 Pravastatin sodium · Pravastatin Sodium 20 mg/1 · Dr.Reddy's Laboratories Limited
- NDC 55111-229 Pravastatin sodium · Pravastatin Sodium 10 mg/1 · Dr.Reddy's Laboratories Limited
- NDC 55111-274 Pravastatin sodium · Pravastatin Sodium 80 mg/1 · Dr.Reddy's Laboratories Limited
- NDC 55111-231 Pravastatin sodium · Pravastatin Sodium 40 mg/1 · Dr.Reddy's Laboratories Limited