D-0452-2018 Class II Terminated
FDA drug recall D-0452-2018 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
Ketamine HCl Injection 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-0452-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026