Class II
Terminated
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.
This recall has been terminated (originally issued August 15, 2018).
- Company
- Pharmedium Services, Llc
- Recall Initiated
- July 24, 2018
- Posted
- August 15, 2018
- Recall Number
- D-1043-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 230 Intravia Bags
- Firm Location
- Dayton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Distribution
Product was distributed throughout the United States
Lot / Code Info
Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018
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