D-1038-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2017
- Initiation Date
- July 11, 2017
- Termination Date
- April 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 544 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18