NONOXYNOL-9 Recall D-0427-2024
Description: VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
NONOXYNOL-9 Recall D-0427-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0427-2024 |
| Event ID | 94277 |
| Brand | VCF CONTRACEPTIVE |
| Generic Name | NONOXYNOL-9 |
| Manufacturer | NONOXYNOL-9 |
| Original Package? | 1 |
| Active Substance | NONOXYNOL-9 |
| Drug Route | VAGINAL |
| Distribution | USA nationwide. |
| Quantity | 17,280 paper cartons |
| Recall Reason | cGMP Diviations |
| Drug Classification | Class II |
| Drug Code Info | 20240403 |
| Product NDC | 52925-112 |
| Recall Initiation Date | 20240321 |
| Report Date | 20240403 |
| Classification Date | 20240328 |
| Address | 485 S Broadway Ste 27 Hicksville, NY 11801-5071 United States |
| Recalling Firm | Apothecus Pharmaceutical Corp. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 48Q180SH9T |
| Drug Application Number | part333A |
| Structured Product Labeling (SPL ID) | 91d0a4a1-11bd-4163-9667-80ff0b1e8658 |
| Structured Product Labeling (SPL Set ID) | 92f8eee8-2456-4baf-a85e-1335c80d7fcd |
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