Drug product
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
D-0415-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,198 syringes; expanded 1,289 syringes
- Official record key
drug-enforcement:D-0415-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223045053 Exp 11/15/23; 1223046179 Exp 12/28/23; 1223047477 Exp 02/16/24; 1223047602 Exp 02/22/24; 1223047971 Exp 03/14/24; 1223048269 Exp 03/27/24 Expanded lot#: 1223048181, exp. date 03/22/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility