CEPHALEXIN Recall D-0539-2024
Description: Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9206-1.
CEPHALEXIN Recall D-0539-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0539-2024 |
| Event ID | 94605 |
| Brand | CEPHALEXIN |
| Generic Name | CEPHALEXIN |
| Manufacturer | CEPHALEXIN |
| Active Substance | CEPHALEXIN |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 190 bottles |
| Recall Reason | Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g' |
| Drug Classification | Class III |
| Drug Code Info | 20240612 |
| Product NDC | 63629-9206 |
| 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) | 73448cfa-20f5-4e38-9df0-4da47a647f8f |
| Structured Product Labeling (SPL Set ID) | 06c2fb2e-0539-4f16-bac4-e15a575ca802 |
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