10 mcg/mL Fentanyl Citrate in 0 recalled over manufacturing violations
- Recall date
- July 24, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- PharMEDium Services, LLC recalls 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fent…
- Recall number
- D-1043-2018
- FDA classification
- Class II
- Brand / firm
- PharMEDium Services, LLC
- Sold / distributed
- Product was distributed throughout the United States
Why it was recalled
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
Get recall alerts
Free email alert whenever PharMEDium Services, LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: PharMEDium Services, LLC