Why it was recalled
Lack of Assurance of Sterility
Product description
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
Lot numbers, UPCs & expiration codes
Lot #: 1223045040 Exp 11/13/23, 1223046397 Exp 01/06/24, 1223046505 Exp 01/10/24, 1223047254 Exp 02/08/24, 1223047436 Exp 02/15/24, 1223047938 Exp 03/13/24, 1223049150 Exp 05/02/24, 1223049300 Exp 05/09/24, Expanded Lot #: 1223048569, Exp 04/06/2024; 1223049600, Exp 05/19/2024
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-0418-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2023
- FDA report date
- Apr 3, 2024
- Quantity
- 10,017 syringes, expanded 2579 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0418-2024, 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 #: 1223045040 Exp 11/13/23, 1223046397 Exp 01/06/24, 1223046505 Exp 01/10/24, 1223047254 Exp 02/08/24, 1223047436 Exp 02/15/24, 1223047938 Exp 03/13/24, 1223049150 Exp 05/02/24, 1223049300 Exp 05/09/24, Expanded Lot #: 1223048569, Exp 04/06/2024; 1223049600, Exp 05/19/2024
- Postal code
- 06095-1024
- Report date
- Apr 3, 2024
- Product type
- Drugs
- Recall number
- D-0418-2024
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals, LLC
- Product quantity
- 10,017 syringes, expanded 2579 syringes
- Termination date
- Aug 27, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 22, 2024