Drug product
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
D-1058-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,077 syringes
- Official record key
drug-enforcement:D-1058-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270770, Exp. 7/19/2023; 17-271061, Exp. 7/24/2023; 17-271419, Exp. 7/30/2023; 17-271678, Exp. 8/2/2023; 17-272124, Exp. 8/10/2023; 17-272302, Exp. 8/14/2023; 17-272518, Exp. 8/17/2023; 17-273493, Exp. 9/4/2023; 17-273671, Exp. 9/6/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility