SUN PHARMACEUTICAL INDUSTRIES INC: Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed

Hazard

Failed Dissolution Specifications: Out of specification for dissolution.

Details from the source

Reason for recall: Failed Dissolution Specifications: Out of specification for dissolution. Distribution: Nationwide in the U.S. Quantity: 54,960 bottles Lot/code info: Lot #s: MHD0606A, MHD0612A, Exp. 04/30/2024; MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, Exp. 05/31/2024; MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, Exp. 06/30/2024; MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A, Exp. 07/31/2024; MHD1081A, MHD1082A, MHD1087A Exp. 09/30/2024.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.