FDA Drug Recalls

Recalls / Class II

Class IID-1302-2020

Product

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07

Affected lot / code info
Lot#: 30010515

Why it was recalled

Subpotent drug - Product did not contain drug.

Recalling firm

Firm
QuVa Pharma, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1075 W Park One Dr Ste 100, N/A, Sugar Land, Texas 77478-2576

Distribution

Quantity
648 bags
Distribution pattern
USA Nationwide

Timeline

Recall initiated
2020-05-28
FDA classified
2020-06-11
Posted by FDA
2020-06-17
Terminated
2022-01-19
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1302-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls