D-0391-2019 Class III Terminated

Recalled by Sun Pharmaceutical Industries, Inc. — Cranbury, NJ

Recall Details

Product Type
Drugs
Report Date
January 30, 2019
Initiation Date
December 26, 2018
Termination Date
April 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5040 cartons

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

Reason for Recall

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

Distribution Pattern

OH

Code Information

Lot: 2979325, EXP 5/5021