FDA Drug recall D-0385-2022
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tabl…
- FDA Drug
- Class III
- terminated
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class III recall of CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tabl… by Dr Reddy S Laboratories, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0385-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-01-04 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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.
Reason
Failed Dissolution Specifications
Identifiers
| upc | 050428436189 |
|---|---|
| upc | 050428290538 |
| code_info | 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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0385-2022%22
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