Recalls / Class II
Class IID-0273-2024
Product
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.
- Brand name
- Fexofenadine Hydrochloride
- Generic name
- Fexofenadine Hydrochloride
- Active ingredient
- Fexofenadine Hydrochloride
- Route
- Oral
- NDCs
- 51660-998, 51316-800
- FDA application
- ANDA091567
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- OHM LABORATORIES INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 54,504 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-01-18
- FDA classified
- 2024-01-25
- Posted by FDA
- 2024-01-31
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0273-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.