Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Rosuvastatin Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
Affected NDC
68788-7971-03
Compare with the code on your package — it is the most precise check available.
Drug: Rosuvastatin Category: Cholesterol Medication
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- NDC code
- 68788-7971-3
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0520-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Rosuvastatin recalls
See all
Class II · Moderate risk
Rosuvastatin Tablets 40mg
CGMP Deviations
Class II · Moderate risk
Rosuvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Rosuvastatin 40mg tablets
cGMP Deviations
Class II · Moderate risk
Rosuvastatin 10mg tablets
cGMP Deviations
Other recalls by Preferred Pharmaceuticals, Inc.
All 2023 recalls
Class II · Moderate risk
Artificial Tears Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Clindamycin Hydrochloride Capsules
cGMP Deviations
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.