FDAFDA · Food and drugs·Recall number D-0558-2020
fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50
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: 10029773 Exp. 11/17/2019, 10029821 Exp. 11/18/2019, 10030351 Exp. 11/21/2019, 10031014 Exp. 12/2/2019, 10030351 Exp. 11/21/2019, 10030912 Exp. 12/2/2019, 10030569 Exp. 11/28/2019, 10030966 Exp. 12/3/2019, 10031796 Exp. 12/23/2019, 10031509 Exp. 12/17/2019, 10031067 Exp. 12/5/2019, 10031156 Exp. 12/16/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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