FDAFDA · Food and drugs·Recall number D-0568-2020
fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Published December 11, 2019 · Recall initiated: November 12, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- QuVa Pharma, Inc.
- Distributor
- Nationwide.
- Lot
- Lots: 10029972 Exp. 11/21/2019, 10030562 Exp. 11/28/2019, 10031447 Exp. 12/15/2019, 10031341 Exp. 12/15/2019, 10031630 Exp. 12/19/2019, 10031748 Exp. 12/22/2019, 10032817 Exp. 1/8/2020, 10033208 Exp. 1/19/2020, 10032887 Exp. 1/12/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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