CEPHALEXIN Recall D-0537-2024
Description: Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.
CEPHALEXIN Recall D-0537-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0537-2024 |
| Event ID | 94605 |
| Brand | CEPHALEXIN |
| Generic Name | CEPHALEXIN |
| Manufacturer | CEPHALEXIN |
| Active Substance | CEPHALEXIN |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 6 bottles |
| Recall Reason | Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g |
| Drug Classification | Class III |
| Drug Code Info | 20240612 |
| Product NDC | 63629-9205 |
| Recall Initiation Date | 20240510 |
| Report Date | 20240612 |
| Classification Date | 20240604 |
| Address | 1919 N Victory PlN/A Burbank, CA 91504-3425 United States |
| Recalling Firm | Bryant Ranch Prepack, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | OBN7UDS42Y |
| Drug Application Number | ANDA210221 |
| Structured Product Labeling (SPL ID) | 5717741b-b550-45ca-8998-2b708cc087fd |
| Structured Product Labeling (SPL Set ID) | a8f14231-5d43-46f7-ba1f-d6de8162d5e7 |
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