Recalls / Class II
Class IID-0418-2024
Product
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.
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 10,017 syringes, expanded 2579 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-11-09
- FDA classified
- 2024-03-22
- Posted by FDA
- 2024-04-03
- Terminated
- 2024-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0418-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.