Drug product
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65
D-0935-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 275 syringes
- Official record key
drug-enforcement:D-0935-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: Lot # 5/16/18 1207 22265S, BUD 8/14/2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility