D-0273-2024 Class II
FDA drug recall D-0273-2024 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: 54,504 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 31, 2024
- Initiation Date
- Jan 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,504 bottles
Product Description
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
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: a) DNE0792A Exp. 06/31/2025; DNE1027A Exp. 08/31/2025. b) DNE0793A Exp. 06/31/2025. c) DNE0789A, DNE0790A, DNE0791A Exp. 06/2025, DNE1026A Exp. 08/31/025.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0273-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026