December 2018 FDA Recall Loperamide Hydrochloride by Sun Pharmaceutical Industries, Inc.
D-0391-2019 - Labeling Not Elsewhere Classified
This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on December 26, 2018 for the product Loperamide Hydrochloride. The FDA reported the reason for recall as labeling not elsewhere classified. The product was distributed in OH and the recall is currently terminated.
Recall Number: D-0391-2019
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
12-26-2018
01-30-2019
5040 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
OH
04-02-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
