FDAFDA · Food and drugs·Recall number D-0946-2018
fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-278-86
Published July 25, 2018 · Recall initiated: June 12, 2018
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
Lack of Assurance of Sterility: Potential leakage of bags.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 5/14/18 1012 172-27886Y, BUD 6/28/2018.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.