Why it was recalled
Lack of sterility assurance.
Product description
BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Lot numbers, UPCs & expiration codes
Lot: 12122019@27 Exp. 12/21/2019
Where it was sold
Nationwide within the United States
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-0698-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 1 syringe
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Assurance Infusion
Original FDA data
Every field from FDA enforcement report D-0698-2020, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 84546
- Address
- 2626 S Loop W Ste 555
- Code information
- Lot: 12122019@27 Exp. 12/21/2019
- Postal code
- 77054-2652
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0698-2020
- Classification
- Class II
- Recalling firm
- Assurance Infusion
- Product quantity
- 1 syringe
- Termination date
- Oct 27, 2021
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2020