Drug recalls

Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical I…

SUN PHARMACEUTICAL INDUSTRIES INC · CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IICompletedD-0268-2024
Status
Completed
City
Princeton
State
NJ
Country
United States
Classification
Class II
Product type
Drugs
Event ID
93820
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address 1
2 Independence Way
Address 2
N/A
Postal code
08540-6620
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA
Recall number
D-0268-2024
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 date
20240118
Center classification date
20240125
Report date
20240131
Code info
Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025.
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.

Harmonized identifiers (openFDA)
Application number
ANDA211858
Brand name
MESALAMINE
Generic name
MESALAMINE
Manufacturer name
Sun Pharmaceutical Industries, Inc.
Product NDC
63304-175
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
MESALAMINE
RxCUI
686429
SPL ID
3f29d761-eab5-4f6b-a4f4-ffcc072648e3
SPL set ID
fd8b02de-7dfa-444d-a1f8-1436b578e0cb
Package NDC
63304-175-13
Is original packager
true
Nui
N0000175781, M0000971
Pharm class epc
Aminosalicylate [EPC]
Pharm class cs
Aminosalicylic Acids [CS]
UNII
4Q81I59GXC
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.