Drug product
Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
D-0019-2018
Product summary
- Event
- Event 78227
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1658 syringes
- Official record key
drug-enforcement:D-0019-2018
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: 041817S5, Exp 10/15/2017; 052417S2, Exp 11/20/2017; 071117S4, Exp 1/7/2018; 0712217S4, Exp 1/8/2018; 080317S6, Exp 1/30/2018; 082217S5, Exp 2/1/2018
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility