D-0166-2019 Class II Terminated
FDA drug recall D-0166-2019 was initiated by Pharm D Solutions, LLC on Sep 10, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Feb 5, 2021). Affected quantity: 896 vials; 64000 milliliters.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 7, 2018
- Initiation Date
- Sep 10, 2018
- Termination Date
- Feb 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 896 vials; 64000 milliliters
Product Description
Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Lot: a) 09042018:66/A Discard by: 3/3/2019; 07302018:65 Discard by: 1/26/2019; b) 08132018:75/A Discard by: 2/1/2019; 04172018:16 Discard by: 9/30/2018; 03212018:27 Discard by: 9/17/2018; 04242018:82 Discard by: 10/20/2018; 05142018:72 Discard by: 11/10/2018; 06192018:67 Discard by: 12/18/2018; 08142018:00 Discard by: 2/1/2019; 07302018:64 Discard by: 1/26/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0166-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026