FEXOFENADINE HYDROCHLORIDE Recall D-0275-2022
Description: Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.
FEXOFENADINE HYDROCHLORIDE Recall D-0275-2022 Information
| Status | Ongoing |
| Recall Number | D-0275-2022 |
| Event ID | 89042 |
| Brand | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI |
| Generic Name | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI |
| Manufacturer | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI |
| Original Package? | 1 |
| Active Substance | FEXOFENADINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | USA Nationwide. |
| Quantity | 2,928 cartons |
| Recall Reason | Failed dissolution specifications |
| Drug Classification | Class III |
| Drug Code Info | 20211215 |
| Product NDC | 43598-823 |
| 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) | d024126e-de41-3d5e-73d8-bbb2623037e6 |
| Structured Product Labeling (SPL Set ID) | 6fd05737-d996-b5b6-dccf-bc179a9d606c |
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