Recalls / Class II
Class IID-0723-2018
Product
LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
- Affected lot / code info
- Lots: LDP/100317 Discard by 4/1/2018; LDP/011618 Discard by 7/15/2018; CALDP/020118 Discard by 7/31/2018; CALDP/012918 Discard by 3/30/2018; CALDP/021518 Discard by 4/16/2018
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
- 1457 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-0723-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.