FDAFDA · Food and drugs·Recall number D-0944-2018
fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-87
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 0913 320-25087Y, BUD 6/28/2018.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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