PHENYTOIN SODIUM Recall D-0070-2023
Description: Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
PHENYTOIN SODIUM Recall D-0070-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0070-2023 |
| Event ID | 91149 |
| Brand | PHENYTOIN SODIUM |
| Generic Name | PHENYTOIN SODIUM |
| Manufacturer | PHENYTOIN SODIUM |
| Original Package? | 1 |
| Active Substance | PHENYTOIN SODIUM |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide in the USA. |
| Quantity | 637 cartons |
| Recall Reason | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. |
| Drug Classification | Class III |
| Drug Code Info | 20221130 |
| Product NDC | 42192-614 |
| Recall Initiation Date | 20221114 |
| Report Date | 20221130 |
| Classification Date | 20221123 |
| Address | 1880 Mcfarland Pkwy Ste 110 Alpharetta, GA 30005-1795 United States |
| Recalling Firm | Acella Pharmaceuticals, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4182431BJH |
| Drug Application Number | ANDA040573 |
| Structured Product Labeling (SPL ID) | eb8e2bf6-9e8b-fdd1-e053-2a95a90a6be4 |
| Structured Product Labeling (SPL Set ID) | 6922f32f-8bed-4c09-8103-27987bcbd104 |
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