Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason CGMP Deviations
Pravastatin Sodium Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
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.
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- NDC code
- 55111-229-90
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1038-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Pravastatin recalls
See all
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets 80mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason Failed Dissolution Specifications: results below specifications
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.