FEXOFENADINE HYDROCHLORIDE Recall D-0268-2022
Description: Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
FEXOFENADINE HYDROCHLORIDE Recall D-0268-2022 Information
| Status | Ongoing |
| Recall Number | D-0268-2022 |
| Event ID | 89042 |
| Brand | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI |
| 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 | 14976 cartons |
| Recall Reason | Failed dissolution specifications |
| Drug Classification | Class III |
| Drug Code Info | 20211215 |
| Product NDC | 69842-249 |
| 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) | e441b034-f450-a8e3-e9c0-9d93f884c742 |
| Structured Product Labeling (SPL Set ID) | d106f6b3-36df-e926-c298-b030dc79dbe6 |
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