Why it was recalled
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product description
fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
Lot numbers, UPCs & expiration codes
Lots: 10029289 Exp. 11/14/2019 10029841 Exp. 11/19/2019, 10029861 Exp. 11/19/2019, 10029863 Exp. 11/19/2019, 10030008 Exp. 11/24/2019, 10029946 Exp. 11/21/2019, 10030009 Exp. 11/24/2019, 10030010 Exp. 11/24/2019, 10030483 Exp. 11/27/2019, 10030482 Exp. 11/27/2019, , 10030958 Exp. 12/3/2019, , 10030908 Exp. 12/2/2019, 10030430 Exp. 11/26/2019, 10030989 Exp. 12/4/2019, 10030959 Exp. 12/3/2019, 10030907 Exp. 12/2/2019, 10030908 Exp. 12/2/2019, 10031283 Exp. 12/11/2019, 10031345 Exp. 12/12/2019, 10031346 Exp. 12/12/2019, 10031477 Exp. 12/16/2019, 10031433 Exp. 12/15/2019, 10031434 Exp. 12/15/2019, 10031478 Exp. 12/16/2019, 10031568 Exp. 12/18/2019, 10031615 Exp. 12/19/2019, 10031479 Exp. 12/18/2019, 10031568 Exp. 12/18/2019, 10031569 Exp. 12/18/2019, 10031570 Exp. 12/18/2019, 10031642 Exp. 12/20/2019, 10031591 Exp. 12/19/2019, 10031813 Exp. 12/23/2019, 10031814 Exp. 12/23/2019, 10032008 Exp. 12/27/2019, 10032009 Exp. 12/27/2019, 10031759 Exp. 12/26/2019, 10031946 Exp. 12/26/2019, 10031846 Exp. 12/24/2019, 10032250 Exp. 12/30/2019, 10031845 Exp. 12/24/2019, 10031846 Exp. 12/24/2019, 10032366 Exp. 1/1/2020, 10032391 Exp. 1/1/2020, , 10032333 Exp. 12/31/2019, 10032445 Exp. 1/2/2020, 10031760 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10032664 Exp. 1/8/2020, 10032665 Exp. 1/8/2020, 10032533 Exp. 1/7/2020, , 10032614 Exp. 1/7/2020, 10032615 Exp. 1/7/2020
Where it was sold
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-0547-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 12, 2019
- FDA report date
- Dec 11, 2019
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- QuVa Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0547-2020, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 84263
- Address
- 1075 W Park One Dr Ste 100
- Code information
- Lots: 10029289 Exp. 11/14/2019 10029841 Exp. 11/19/2019, 10029861 Exp. 11/19/2019, 10029863 Exp. 11/19/2019, 10030008 Exp. 11/24/2019, 10029946 Exp. 11/21/2019, 10030009 Exp. 11/24/2019, 10030010 Exp. 11/24/2019, 10030483 Exp. 11/27/2019, 10030482 Exp. 11/27/2019, , 10030958 Exp. 12/3/2019, , 10030908 Exp. 12/2/2019, 10030430 Exp. 11/26/2019, 10030989 Exp. 12/4/2019, 10030959 Exp. 12/3/2019, 10030907 Exp. 12/2/2019, 10030908 Exp. 12/2/2019, 10031283 Exp. 12/11/2019, 10031345 Exp. 12/12/2019, 10031346 Exp. 12/12/2019, 10031477 Exp. 12/16/2019, 10031433 Exp. 12/15/2019, 10031434 Exp. 12/15/2019, 10031478 Exp. 12/16/2019, 10031568 Exp. 12/18/2019, 10031615 Exp. 12/19/2019, 10031479 Exp. 12/18/2019, 10031568 Exp. 12/18/2019, 10031569 Exp. 12/18/2019, 10031570 Exp. 12/18/2019, 10031642 Exp. 12/20/2019, 10031591 Exp. 12/19/2019, 10031813 Exp. 12/23/2019, 10031814 Exp. 12/23/2019, 10032008 Exp. 12/27/2019, 10032009 Exp. 12/27/2019, 10031759 Exp. 12/26/2019, 10031946 Exp. 12/26/2019, 10031846 Exp. 12/24/2019, 10032250 Exp. 12/30/2019, 10031845 Exp. 12/24/2019, 10031846 Exp. 12/24/2019, 10032366 Exp. 1/1/2020, 10032391 Exp. 1/1/2020, , 10032333 Exp. 12/31/2019, 10032445 Exp. 1/2/2020, 10031760 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10032664 Exp. 1/8/2020, 10032665 Exp. 1/8/2020, 10032533 Exp. 1/7/2020, , 10032614 Exp. 1/7/2020, 10032615 Exp. 1/7/2020
- Postal code
- 77478-2576
- Report date
- Dec 11, 2019
- Product type
- Drugs
- Recall number
- D-0547-2020
- Classification
- Class II
- Recalling firm
- QuVa Pharma, Inc.
- Termination date
- Jun 5, 2020
- Reason for recall
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 3, 2019