Drug product
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.
D-0380-2022
Product summary
- Event
- Event 89364
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,080 boxes
- Official record key
drug-enforcement:D-0380-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: AC2103330D, Exp.1/31/2023; AC2106452E, Exp. 3/31/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications