Drug product
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
D-0166-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 896 vials; 64000 milliliters
- Official record key
drug-enforcement:D-0166-2019
Official wording
Reason: Lack of Assurance of Sterility
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
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility