D-0446-2018 Class II Terminated
FDA drug recall D-0446-2018 was initiated by Pharmedium Services, LLC on Dec 27, 2017 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated May 7, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 28, 2018
- Initiation Date
- Dec 27, 2017
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging.
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
U.S.A. Nationwide
Code Information
All lots remaining within expiry.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0446-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026