← FDA ENFORCEMENT
D-0350-2024Class II

SUN PHARMACEUTICAL INDUSTRIES INC

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product type
Drug
Status
Ongoing
Report date
2024-03-06
Distribution
Nationwide in the U.S.
Firm state
NJ
Product quantity
54,960 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

Product description

Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.

Code / lot 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.

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.