Recalls / Class II
Class IID-0526-2023
Product
Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7
- Brand name
- Tadalafil
- Generic name
- Tadalafil
- Active ingredient
- Tadalafil
- Route
- Oral
- NDC
- 68788-8153
- FDA application
- ANDA209167
- Affected lot / code info
- Lot: C0822E, Exp 1/31/2024, F1121B, Exp 1/31/2024, G2721L, Exp 1/31/2024.
Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 32 Bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-03-23
- FDA classified
- 2023-04-06
- Posted by FDA
- 2023-04-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0526-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.