Status
Terminated
Drug Enforcement D-0417-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Report Date
March 8, 2023
Termination Date
April 22, 2024
Product Information
- Product description
- Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Product quantity
- 613,553 bottles
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States including Puerto Rico and Canada
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0417-2023
- Event ID
- 91657
- Recall initiation date
- February 7, 2023
- Center classification date
- March 2, 2023
- Code info
- Batches: a) P2002461, Exp. Date 4/30/2023; P2002457, Exp. Date 4/30/2023; P2002460, Exp. Date 4/30/2023; P2002464, Exp. Date 4/30/2023; P2002463, Exp. Date 4/30/2023; P2002462, Exp. Date 4/30/2023; P2002465, Exp. Date 4/30/2023; P2003153, Exp. Date 5/31/2023; P2003155, Exp. Date 5/31/2023; P2003156, Exp. Date 5/31/2023; P2003154, Exp. Date 5/31/2023; P2003152, Exp. Date 5/31/2023; P2003157, Exp. Date 5/31/2023; P2003158, Exp. Date 5/31/2023; P2003159, Exp. Date 5/31/2023; P2003162, Exp. Date 5/31/2023; P2003160, Exp. Date 5/31/2023; P2003778, Exp. Date 6/30/2023; P2003779, Exp. Date 6/30/2023; P2004315, Exp. Date 6/30/2023; P2004818, Exp. Date 8/31/2023; P2004819, Exp. Date 8/31/2023; P2005158, Exp. Date 8/31/2023; P2005156, Exp. Date 8/31/2023; P2005157, Exp. Date 8/31/2023; P2005247, Exp. Date 9/30/2023; P2006641, Exp. Date 11/30/2023; P2101002, Exp. Date 1/31/2024; P2101004, Exp. Date 1/31/2024; P2101003, Exp. Date 1/31/2024; P2101006, Exp. Date 1/31/2024; P2101005, Exp. Date 1/31/2024; P2101008, Exp. Date 1/31/2024; P2101023, Exp. Date 1/31/2024; P2101022, Exp. Date 1/31/2024; P2101274, Exp. Date 2/29/2024; P2202085, Exp. Date 3/31/2025; b) P2002467, Exp. Date 4/30/2023; P2002466, Exp. Date 4/30/2023; P2002468, Exp. Date 4/30/2023; P2003780, Exp. Date 6/30/2023; P2005154, Exp. Date 8/31/2023; P2005244, Exp. Date 9/30/2023; P2005246, Exp. Date 9/30/2023; P2005809, Exp. Date 10/31/2023; P2005810, Exp. Date 10/31/2023; P2006642, Exp. Date 11/30/2023; P2006643, Exp. Date 11/30/2023; P2006644, Exp. Date 11/30/2023; P2006645, Exp. Date 11/30/2023; P2006646, Exp. Date 11/30/2023; P2006647, Exp. Date 11/30/2023; P2100463, Exp. Date 12/31/2023; P2100462, Exp. Date 12/31/2023; P2100464, Exp. Date 12/31/2023; P2100465, Exp. Date 12/31/2023; P2100498, Exp. Date 12/31/2023; P2100497, Exp. Date 12/31/2023; P2100499, Exp. Date 12/31/2023; P2100573 ,Exp. Date 1/31/2024; P2100572, Exp. Date 1/31/2024; P2100574, Exp. Date 1/31/2024; P2101007, Exp. Date 1/31/2024; P2202084, Exp. Date 3/31/2025;
- More code info
- —