Drug product
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.
D-0385-2022
Product summary
- Event
- Event 89364
- Status
- Terminated
- Classification
- Class III
- Quantity
- 41,784 boxes
- Official record key
drug-enforcement:D-0385-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #s: a) (20-count): AC2000968A; AC2000968F, Exp. 8/31/2022. b) (30-count): 79C002624B, Exp. 4/30/2022; AC2103330G; AC2103330H, Exp. 1/31/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications