Why it was recalled
Lack of Assurance of Sterility
Product description
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
Lot numbers, UPCs & expiration codes
Lot #: 1223048522, Exp 12/07/23; 1223049168, Exp 01/04/24; 1223049552, Exp 01/19/24
Where it was sold
Nationwide in the USA
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-0402-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2023
- FDA report date
- Apr 3, 2024
- Quantity
- 1,259 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0402-2024, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 93456
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot #: 1223048522, Exp 12/07/23; 1223049168, Exp 01/04/24; 1223049552, Exp 01/19/24
- Postal code
- 06095-1024
- Report date
- Apr 3, 2024
- Product type
- Drugs
- Recall number
- D-0402-2024
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals, LLC
- Product quantity
- 1,259 syringes
- Termination date
- Aug 27, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 22, 2024