D-0977-2017 Class II Terminated
FDA drug recall D-0977-2017 was initiated by SCA Pharmaceuticals on June 21, 2017 and is designated Class II. Reason for recall: Lack of sterility assurance The recall status is terminated (terminated April 3, 2019). Affected quantity: 660 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2017
- Initiation Date
- June 21, 2017
- Termination Date
- April 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 660 bags
Product Description
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
Reason for Recall
Lack of sterility assurance
Distribution Pattern
LA, PA, NY, WI
Code Information
Lot #: 20170509@6, Exp 6/23/2017; 20170519@35, Exp 7/3/2017; 20170523@22, Exp 7/7/2017; 20170525@9, Exp 7/9/2017; 20170605@49, Exp 7/20/2017; 20170605@9, Exp 7/20/2017