Dr. Reddy's Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (ND…
- Recall date
- July 11, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1038-2017
- FDA classification
- Class III
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Class III means the product violates regulations but is not likely to cause harm.
What 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.
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