Drug product
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
D-0015-2018
Product summary
- Event
- Event 78227
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1359 bags
- Official record key
drug-enforcement:D-0015-2018
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: 071817S1, Exp 10/18/2017; 072417S1, Exp 10/24/2017; 072517S1, Exp 10/25/2017; 081117S1, Exp 11/11/2017; 081517S1, Exp 11/15/2017; 082217S1, Exp 11/22/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility