FDAFDA · Food and drugs·Recall number D-1038-2017
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.
Published August 9, 2017 · Recall initiated: July 11, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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