D-0067-2018 Class II Terminated
FDA drug recall D-0067-2018 was initiated by SCA Pharmaceuticals, LLC on October 19, 2017 and is designated Class II. Reason for recall: Lack Of Assurance Of Sterility. The recall status is terminated (terminated May 1, 2019). Affected quantity: 76 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- November 8, 2017
- Initiation Date
- October 19, 2017
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 bags
Product Description
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
Reason for Recall
Lack Of Assurance Of Sterility.
Distribution Pattern
Nationwide in the United States
Code Information
Lot: 20170920@20 BUD: 11/09/2017