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.
Reported: August 15, 2018 Initiated: July 24, 2018 #D-1043-2018
Product Description
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.
Reason for Recall
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Details
- Recalling Firm
- PharMEDium Services, LLC
- Units Affected
- 230 Intravia Bags
- Distribution
- Product was distributed throughout the United States
- Location
- Dayton, NJ
Frequently Asked Questions
What product 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.. Recalled by PharMEDium Services, LLC. Units affected: 230 Intravia Bags.
Why was this product recalled? ▼
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 15, 2018. Severity: Moderate. Recall number: D-1043-2018.
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