D-0268-2024 Class II
FDA drug recall D-0268-2024 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jan 18, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Affected quantity: 10,690 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 31, 2024
- Initiation Date
- Jan 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,690 bottles
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.
Reason for Recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0268-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026