Drug Enforcement D-0350-2024

Failed Dissolution Specifications: Out of specification for dissolution.

Status

Ongoing

Classification

Class II

Report Date

March 6, 2024

Termination Date

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Product Information

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.
Product quantity
54,960 bottles
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the U.S.

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0350-2024
Event ID
93909
Recall initiation date
February 5, 2024
Center classification date
February 23, 2024
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.
More code info
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