Drug 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.
D-1038-2017
Product summary
- Event
- Event 77734
- Status
- Terminated
- Classification
- Class III
- Quantity
- 544 bottles
- Official record key
drug-enforcement:D-1038-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Code information: Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification