Fexofenadine Hydrochloride Tablet
FDA Recall NDC 51316-800
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fexofenadine Hydrochloride (NDC 51316-800). A significant event, classified as Class II, was initiated on Jan 18, 2024 by Cvs Pharmacy, Inc. The reported reason for this action was: "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Jan 18, 2024
Jan 31, 2024
54,504 bottles
Recall Profile & Regulatory Data
Event ID
93820
Classification
Class II
Enforcement Status
Completed
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration 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.
Affected Packages Involved in this Recall
51660-998-30Product
51660-998-55Product
51316-800-90Product
51316-800-70Product
51316-800-45Product
51316-800-30Product
51316-800-15Product
51316-800-08Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
