CEFIXIME Recall D-0359-2022
Description: Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
CEFIXIME Recall D-0359-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0359-2022 |
| Event ID | 89259 |
| Brand | CEFIXIME |
| Generic Name | CEFIXIME |
| Manufacturer | CEFIXIME |
| Original Package? | 1 |
| Active Substance | CEFIXIME |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 42,698 bottles |
| Recall Reason | Failed impurities/degradation specifications |
| Drug Classification | Class II |
| Drug Code Info | 20220112 |
| Product NDC | 67877-584 |
| Recall Initiation Date | 20211221 |
| Report Date | 20220112 |
| Classification Date | 20220105 |
| Address | 339 Jefferson Rd Ste 101 Parsippany, NJ 07054-3707 United States |
| Recalling Firm | Ascend Laboratories, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 97I1C92E55 |
| Drug Application Number | ANDA210574 |
| Structured Product Labeling (SPL ID) | fe4acd5e-1980-46b0-a87d-589508766117 |
| Structured Product Labeling (SPL Set ID) | 6f1df975-f825-4301-87da-d7eba56a6890 |
| Similar To |