Why it was recalled
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
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.
Lot numbers, UPCs & expiration codes
Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018
Where it was sold
Product was distributed throughout the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1043-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 230 Intravia Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMEDium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1043-2018, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80638
- Address
- 36 Stults Rd
- Code information
- Lot 181760013D, 181730007D, Exp 08/09/2018, 09/02/2018
- Postal code
- 08810
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1043-2018
- Classification
- Class II
- Recalling firm
- PharMEDium Services, LLC
- Product quantity
- 230 Intravia Bags
- Termination date
- Dec 10, 2018
- Reason for recall
- CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was distributed throughout the United States
- Recall initiation date
- Jul 24, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2018