Recalls / Class II
Class IID-0724-2018
Product
LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
- Affected lot / code info
- Lots: LP/100617 Discard by 4/4/2018; LP/101817 Discard by 4/16/2018; LP/103117 Discard by 4/29/2018; LP/110817 Discard by 5/7/2018; LP/111617 Discard by 5/15/2018; LP/120617 Discard by 6/4/2018; LP/120817 Discard by 6/6/2018; LP/121417 Discard by 6/12/2018; LP/010918 Discard by 7/8/2018; LP/011818 Discard by 07/17/2018; LP/012518 Discard by 7/24/2018; LP/020818 Discard by 8/7/2018; LP/021618 Discard by 8/15/2018; CALP/021218 Discard by 4/13/2018
Why it was recalled
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Recalling firm
- Firm
- Coastal Meds, LLC.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1759 Medical Park Dr Ste C, N/A, Biloxi, Mississippi 39532-2154
Distribution
- Quantity
- 8099 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-04-05
- FDA classified
- 2018-05-09
- Posted by FDA
- 2018-05-02
- Terminated
- 2020-11-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0724-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.