Class II · Moderate risk
Tadalafil USP
CGMP Deviations:Noted during FDA inspection
Tadalafil 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
Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7
Affected NDC
68788-8153-07
Compare with the code on your package — it is the most precise check available.
Drug: Tadalafil
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tadalafil NDC 68788-8153 |
20 mg/1 | Tablet, Film Coated Oral |
Preferred Pharmaceuticals Inc. | Rx |
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- NDC code
- 68788-8153-7
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0526-2023 · 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 Tadalafil recalls
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Class II · Moderate risk
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Class II · Moderate risk
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CGMP Deviations:Noted during FDA inspection
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