FDAFDA · Food and drugs·Recall number D-0569-2020
fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, 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: 10030890 Exp. 12/2/2019, 10031264 Exp. 12/10/2019, 10031093 Exp. 12/6/2019, 10032337 Exp. 12/31/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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