D-0391-2019 Class III Terminated
FDA drug recall D-0391-2019 was initiated by Sun Pharmaceutical Industries, Inc. on Dec 26, 2018 and is designated Class III. 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. The recall status is terminated (terminated Apr 2, 2020). Affected quantity: 5040 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 30, 2019
- Initiation Date
- Dec 26, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0391-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026