FDAFDA · Food and drugs·Recall number D-1043-2018
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
Published August 15, 2018 · Recall initiated: July 24, 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
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PharMEDium Services, LLC
- Distributor
- Product was distributed throughout the United States
- Lot
- Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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