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
D-0391-2019
Product summary
- Event
- Event 81893
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5040 cartons
- Official record key
drug-enforcement:D-0391-2019
Official wording
Reason: Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Code information: Lot: 2979325, EXP 5/5021
Distribution pattern: OH
Derived failure modes
-
Unknown
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.