Drug recall D-0391-2019

Class III Terminated reported Jan 30, 2019

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

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.

Lots and codes

Lot: 2979325, EXP 5/5021

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
5040 cartons
Distribution
OH
Type
Voluntary: Firm initiated
Recall initiated
December 26, 2018
Terminated
April 2, 2020

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