FDAFDA · Food and drugs·Recall number D-0563-2020
fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36
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: 10029201 Exp. 11/17/2019, 10029983 Exp. 11/22/2019, 10029987 Exp. 11/22/2019, 10030428 Exp. 11/26/2019, 10030879 Exp. 11/28/2019, 10031240 Exp. 12/10/2019, 10031241 Exp. 12/10/2019, 10031344 Exp. 12/12/2019, 10031343 Exp. 12/12/2019, 10031394 Exp. 12/12/2019, 10031612 Exp. 12/19/2019, 10031665 Exp. 12/20/2019, 10031666 Exp. 12/20/2019, 10031590 Exp. 12/18/2019, 10031787 Exp. 12/23/2019, 10032036 Exp. 12/27/2019, 10032305 Exp. 12/31/2019, 10032444 Exp. 1/2/2020, 10033172 Exp. 1/12/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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