Class II · Moderate risk
Finasteride 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
Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Affected NDCs
68788-6976-03
68788-6976-09
Compare with the code on your package — it is the most precise check available.
Drug: Finasteride
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- NDC code
- 68788-6976-3
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0516-2023 · 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 Finasteride recalls
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Class II · Moderate risk
Finasteride
cGMP deviations
Class II · Moderate risk
Finasteride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Finasteride Tablets USP 1 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Finasteride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
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Class II · Moderate risk
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Class II · Moderate risk
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