Class III
Terminated
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.
This recall has been terminated (originally issued August 9, 2017).
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- July 11, 2017
- Posted
- August 9, 2017
- Recall Number
- D-1038-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 544 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18
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