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Recall Observatory FDA recall evidence

Drug product

LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

D-0724-2018

April 05, 2018

Class II

Product summary

Firm
Coastal Meds, LLC.
Event
Event 79671
Status
Terminated
Classification
Class II
Quantity
8099 vials
Official record key
drug-enforcement:D-0724-2018

Official wording

Reason: Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Code information: 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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate matter