Recall D-1544-2022
Description: oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.
Recall D-1544-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1544-2022 |
| Event ID | 90898 |
| Distribution | Nationwide in the USA |
| Quantity | 1994 bags |
| Recall Reason | Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL). |
| Drug Classification | Class III |
| Drug Code Info | 20221005 |
| Recall Initiation Date | 20220920 |
| Report Date | 20221005 |
| Classification Date | 20220926 |
| Address | 519 State Route 173 Bloomsbury, NJ 08804-4047 United States |
| Recalling Firm | QuVa Pharma, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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