Class II
Terminated
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
- Company
- Accord Healthcare, Inc.
- Recall Initiated
- February 7, 2023
- Posted
- March 8, 2023
- Recall Number
- D-0414-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 36,773 bottles
- Firm Location
- Durham, NC, United States
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution
United States including Puerto Rico and Canada
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;
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