Why it was recalled
Subpotent drug - Product did not contain drug.
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: 30010515
Where it was sold
USA Nationwide
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-1302-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 28, 2020
- FDA report date
- Jun 17, 2020
- Quantity
- 648 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- QuVa Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-1302-2020, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 85773
- Address
- 1075 W Park One Dr Ste 100
- Code information
- Lot#: 30010515
- Postal code
- 77478-2576
- Report date
- Jun 17, 2020
- Product type
- Drugs
- Recall number
- D-1302-2020
- Classification
- Class II
- Recalling firm
- QuVa Pharma, Inc.
- Product quantity
- 648 bags
- Termination date
- Jan 19, 2022
- Reason for recall
- Subpotent drug - Product did not contain drug.
- 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, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 11, 2020