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.
Reported: August 9, 2017 Initiated: July 11, 2017 #D-1038-2017
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.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 544 bottles
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 544 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 9, 2017. Severity: Low. Recall number: D-1038-2017.
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