Why it was recalled
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).
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.
Lot numbers, UPCs & expiration codes
Lot 30027403, BUD 11/14/2022
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1544-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 20, 2022
- FDA report date
- Oct 5, 2022
- Quantity
- 1994 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- QuVa Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-1544-2022, exactly as published.
Show all FDA fields
- City
- Bloomsbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90898
- Address
- 519 State Route 173
- Code information
- Lot 30027403, BUD 11/14/2022
- Postal code
- 08804-4047
- Report date
- Oct 5, 2022
- Product type
- Drugs
- Recall number
- D-1544-2022
- Classification
- Class III
- Recalling firm
- QuVa Pharma, Inc.
- Product quantity
- 1994 bags
- Termination date
- Feb 8, 2023
- 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 20, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 26, 2022