VASOPRESSIN, UNSPECIFIED Recall D-0232-2024
Description: Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
VASOPRESSIN, UNSPECIFIED Recall D-0232-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0232-2024 |
| Event ID | 93805 |
| Brand | VASOSTRICT |
| Generic Name | VASOPRESSIN |
| Manufacturer | VASOPRESSIN |
| Original Package? | 1 |
| Active Substance | VASOPRESSIN, UNSPECIFIED |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide USA |
| Quantity | 1721 cartons |
| Recall Reason | Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit. |
| Drug Classification | Class II |
| Drug Code Info | 20240124 |
| Product NDC | 42023-164 42023-190 42023-219 |
| Drug UPC | 0342023157010 |
| Recall Initiation Date | 20240111 |
| Report Date | 20240124 |
| Classification Date | 20240116 |
| Address | 870 Parkdale Rd Rochester, MI 48307-1740 United States |
| Recalling Firm | Par Sterile Products LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | Y87Y826H08 |
| Drug Application Number | NDA204485 |
| Structured Product Labeling (SPL ID) | a77d5136-3c3a-43ef-a80a-849fae5153a5 |
| Structured Product Labeling (SPL Set ID) | b1147beb-743e-4c62-8927-91192447f8b8 |
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