Drug product
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India.
D-0381-2022
Product summary
- Event
- Event 89364
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,064 boxes
- Official record key
drug-enforcement:D-0381-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #s: AC2000968E, Exp. 8/31/2022; AC2103328A; AC2103330I, Exp. 1/31/2023; AC2106452B, Exp. 3/31/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications