Drug product
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
D-0408-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 399 syringes
- Official record key
drug-enforcement:D-0408-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223048491 Exp 11/21/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility