Drug product
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1016-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2400 syringes
- Official record key
drug-enforcement:D-1016-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 12/03/18 4090 28967S Exp. 4/2/2019; 12/03/18 6221 28967S Exp. 4/2/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility