Recalls / Class III
Class IIID-1544-2022
Product
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.
- Affected lot / code info
- Lot 30027403, BUD 11/14/2022
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).
Recalling firm
- Firm
- QuVa Pharma, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 519 State Route 173, N/A, Bloomsbury, New Jersey 08804-4047
Distribution
- Quantity
- 1994 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-09-20
- FDA classified
- 2022-09-26
- Posted by FDA
- 2022-10-05
- Terminated
- 2023-02-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1544-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.