FEXOFENADINE HYDROCHLORIDE Recall D-0267-2022
Description: Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.
FEXOFENADINE HYDROCHLORIDE Recall D-0267-2022 Information
| Status | Ongoing |
| Recall Number | D-0267-2022 |
| Event ID | 89042 |
| Brand | ALLERGY AND CONGESTION |
| Generic Name | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI |
| Manufacturer | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI |
| Active Substance | FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | USA Nationwide. |
| Quantity | 4896 cartons |
| Recall Reason | Failed dissolution specifications |
| Drug Classification | Class III |
| Drug Code Info | 20211215 |
| Product NDC | 11822-7388 |
| Recall Initiation Date | 20211112 |
| Report Date | 20211215 |
| Classification Date | 20211207 |
| Address | 107 College Rd E Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 2S068B75ZU 6V9V2RYJ8N |
| Drug Application Number | ANDA076667 |
| Structured Product Labeling (SPL ID) | 0855522f-2405-be3c-f917-1eee93ea396a |
| Structured Product Labeling (SPL Set ID) | 90e1aa06-b769-e8ac-af88-1d6a256b9487 |
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