Recalls / Class II
Class IID-1043-2018
Product
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.
- Affected lot / code info
- Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018
Why it was recalled
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Recalling firm
- Firm
- PharMEDium Services, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 36 Stults Rd, N/A, Dayton, New Jersey 08810
Distribution
- Quantity
- 230 Intravia Bags
- Distribution pattern
- Product was distributed throughout the United States
Timeline
- Recall initiated
- 2018-07-24
- FDA classified
- 2018-08-03
- Posted by FDA
- 2018-08-15
- Terminated
- 2018-12-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1043-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.