Class II · Moderate risk Ongoing
Rosuvastatin Tablets
Reason Out of specification for dissolution.
Rosuvastatin 40mg tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations
What was recalled
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
- Recalling firm
- RemedyRepack Inc.
- NDC code
- 70518-1311-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0502-2023
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 Rosuvastatin recalls
See all
Class II · Moderate risk Ongoing
Rosuvastatin Tablets 40mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Rosuvastatin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Ongoing
Rosuvastatin Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Terminated
Rosuvastatin 10mg tablets
Reason cGMP Deviations
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