Recalls / Class II
Class IID-0414-2023
Product
Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Brand name
- Tadalafil
- Generic name
- Tadalafil
- Active ingredient
- Tadalafil
- Route
- Oral
- NDCs
- 16729-369, 16729-370, 16729-371, 16729-372
- FDA application
- ANDA209167
- Affected lot / code info
- Batches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b) P2002521, Exp. Date 4/30/2023; P2005818, Exp. Date 10/31/2023; P2100075, Exp. Date 12/31/2023; P2100996, P2100997, P2100998, P2100999, Exp. Date 1/31/2024;
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 36,773 bottles
- Distribution pattern
- United States including Puerto Rico and Canada
Timeline
- Recall initiated
- 2023-02-07
- FDA classified
- 2023-03-02
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0414-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.