Drug product
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
D-0410-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 909 syringes
- Official record key
drug-enforcement:D-0410-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: 1223048258 Exp 11/10/23; 1223048890 Exp 12/07/23; 1223049134 Exp 12/19/23
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility