Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-492-12 UPC 3 16729 49212 6

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Code information: Batches: P2101582, P2101661, P2101482, P2101686, Exp. Date 2/28/2023; P2102581, P2102598, Exp. Date 4/30/2023; P2103623, P2103653, P2103670, Exp. Date 5/31/2023; P2104463, P2104385, P2104386, P2104472, P2104709, P2104714, Exp. Date 6/30/2023; P2200797, P2200773, P2200831, Exp. Date 12/31/2023; P2201017, P2201081, P2201056, Exp. Date 1/31/2024; P2200819, Exp. Date 12/31/2024; P2202611, P2202616, Exp. Date 4/30/2025, P2203467, Exp. Date 5/31/2025

Distribution pattern: United States including Puerto Rico and Canada