FDA recall D-0391-2019

Sun Pharmaceutical Industries, Inc. · Class III · drug

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.

Distribution

OH

Key facts

Status
Terminated
Initiation date
2018-12-26
Report date
2019-01-30
Termination date
2020-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2019