PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: January 30, 2019 Initiated: December 26, 2018 #D-0391-2019

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.

Details

Units Affected
5040 cartons
Distribution
OH
Location
Cranbury, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 5040 cartons.
Why was this product recalled?
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 30, 2019. Severity: Low. Recall number: D-0391-2019.