Drug product
Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distributed by: Drug Mart -Food Fair, 211 Commerce Drive, Medina, OH 44256.
D-0868-2020
Product summary
- Event
- Event 84938
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3456 Bottles
- Official record key
drug-enforcement:D-0868-2020
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Expiration date.
Code information: Lot #s: a) P138855, Exp. 05/30/2022; b) P138856, Exp. 05/30/2022
Distribution pattern: Ohio
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing