Drug recall
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal…
FDA recall event 89364 · Class III · Dr. Reddy's Laboratories, Inc.
Key facts
| Event ID | 89364 |
|---|---|
| Recall numbers | D-0378-2022, D-0379-2022, D-0380-2022, D-0381-2022, D-0382-2022, D-0383-2022, D-0384-2022, D-0385-2022, D-0386-2022 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Product type | Drugs |
| Products | 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…, Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box…, equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b)…, 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…, Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by… and 4 more |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Dissolution Specifications |
| Initiation date | Jan 4, 2022 |
| Report date | Jan 26, 2022 |
| Termination date | Oct 20, 2023 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003989912 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: