Status
Terminated
Drug Enforcement D-1544-2022
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).
1 Views
Classification
Class III
Report Date
October 5, 2022
Termination Date
February 8, 2023
Product Information
- Product 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.
- Product quantity
- 1994 bags
- Reason for recall
- 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).
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- QuVa Pharma, Inc.
- Address
-
519 State Route 173, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1544-2022
- Event ID
- 90898
- Recall initiation date
- September 20, 2022
- Center classification date
- September 26, 2022
- Code info
- Lot 30027403, BUD 11/14/2022
- More code info
- —