Drug product
HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
D-0031-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,664 30 mL syringes
- Official record key
drug-enforcement:D-0031-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275339, Exp. 10/3/2023; 17-275478, 17-275488, Exp. 10/4/2023; 17-275620, Exp. 10/8/2023; 17-275777, 17-275793, Exp. 10/10/2023; 17-275863, 17-275958, Exp. 10/11/2023; 17-276027, Exp. 10/16/2023; 17-275730, Exp. 10/9/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility