Drug product
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
D-0897-2018
Product summary
- Event
- Event 80303
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,869 bags
- Official record key
drug-enforcement:D-0897-2018
Official wording
Reason: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information: Lot # 1218001315, 1218001316, 1218001349, 1218001416, 1218001510, 1218001682, 1218001683, 1218001684, 1218001721, 1218001763, 1218001764, Exp 07/26/2018-08/27/2018
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility