Loperamide Hydrochloride Tablet
FDA Recall NDC 53943-123
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 Loperamide Hydrochloride (NDC 53943-123). A significant event, classified as Class III, was initiated on Dec 26, 2018 by Discount Drug Mart. The reported reason for this action was: "Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Dec 26, 2018
Jan 30, 2019
5040 cartons
Recall Profile & Regulatory Data
Event ID
81893
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH
Termination Date
Apr 02, 2020
Product Description
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24
Batch or Lot Expiration Information
Lot# Lot: 2979325, EXP 5/5021
Affected Packages Involved in this Recall
53943-123-12Product
53943-123-24Product
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.
