D-1157-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 5, 2018
- Initiation Date
- August 21, 2018
- Termination Date
- January 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167 vials
Product Description
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Reason for Recall
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Distribution Pattern
Nationwide in USA
Code Information
Lot #: 180626/10, Exp 24-Sep-18