Recalls / Class II
Class IID-0166-2019
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
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1304 S Loop W, N/A, Houston, Texas 77054-4010
Distribution
- Quantity
- 896 vials; 64000 milliliters
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-09-10
- FDA classified
- 2018-11-01
- Posted by FDA
- 2018-11-07
- Terminated
- 2021-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0166-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.