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) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
Lot numbers, UPCs & expiration codes
Lots: 10029288 Exp. 11/14/2019, 10029762 Exp. 11/14/2019, 10029788 Exp. 11/18/2019, 10029838 Exp. 11/19/2019, 10029948 Exp. 11/21/2019, 10029949 Exp. 11/21/2019, 10030337 Exp. 11/24/2019, 10029838 Exp. 11/19/2019, 10030539 Exp. 11/28/2019, 10030943 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030963 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030888 Exp. 12/2/2019, 10030963 Exp. 12/3/2019, 10031129 Exp. 12/8/2019, 10031284 Exp. 12/11/2019, 10031414 Exp. 12/15/2019, 10031435 Exp. 12/16/2019, 10031735 Exp. 12/22/2019, 10032253 Exp. 12/30/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10032280 Exp. 12/31/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10033009 Exp. 1/15/2020, 10032585 Exp. 1/14/2020, 10033009 Exp. 1/15/2020
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-0549-2020
- 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-0549-2020, 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: 10029288 Exp. 11/14/2019, 10029762 Exp. 11/14/2019, 10029788 Exp. 11/18/2019, 10029838 Exp. 11/19/2019, 10029948 Exp. 11/21/2019, 10029949 Exp. 11/21/2019, 10030337 Exp. 11/24/2019, 10029838 Exp. 11/19/2019, 10030539 Exp. 11/28/2019, 10030943 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030963 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030888 Exp. 12/2/2019, 10030963 Exp. 12/3/2019, 10031129 Exp. 12/8/2019, 10031284 Exp. 12/11/2019, 10031414 Exp. 12/15/2019, 10031435 Exp. 12/16/2019, 10031735 Exp. 12/22/2019, 10032253 Exp. 12/30/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10032280 Exp. 12/31/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10033009 Exp. 1/15/2020, 10032585 Exp. 1/14/2020, 10033009 Exp. 1/15/2020
- Postal code
- 77478-2576
- Report date
- Dec 11, 2019
- Product type
- Drugs
- Recall number
- D-0549-2020
- 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) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 3, 2019