D-0897-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 11, 2018
- Initiation Date
- June 14, 2018
- Termination Date
- February 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,869 bags
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Lot # 1218001315, 1218001316, 1218001349, 1218001416, 1218001510, 1218001682, 1218001683, 1218001684, 1218001721, 1218001763, 1218001764, Exp 07/26/2018-08/27/2018