Why it was recalled
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Product description
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Lot numbers, UPCs & expiration codes
Lot # 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, Exp 6/26/2018
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-0895-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 14, 2018
- FDA report date
- Jul 11, 2018
- Quantity
- 492 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0895-2018, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 80303
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot # 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, Exp 6/26/2018
- Postal code
- 06095-1024
- Report date
- Jul 11, 2018
- Product type
- Drugs
- Recall number
- D-0895-2018
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals, LLC
- Product quantity
- 492 bags
- Termination date
- Feb 4, 2019
- Reason for recall
- Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Jun 14, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 2, 2018