Drug Enforcement D-0268-2024

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Status

Completed

Classification

Class II

Report Date

January 31, 2024

Termination Date

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Product Information

Product description
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.
Product quantity
10,690 bottles
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0268-2024
Event ID
93820
Recall initiation date
January 18, 2024
Center classification date
January 25, 2024
Code info
Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025.
More code info
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