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Recall Observatory FDA recall evidence

Drug product

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

D-0722-2018

April 05, 2018

Class II

Product summary

Firm
Coastal Meds, LLC.
Event
Event 79671
Status
Terminated
Classification
Class II
Quantity
3733 vials
Official record key
drug-enforcement:D-0722-2018

Official wording

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

Code information: Lots: LE/101917 Discard by 4/17/2018; LE/110317 Discard by 5/2/2018; LE/110917 Discard by 5/8/2018; LE/010318 Discard by 7/2/2018; LE/012218 Discard by 7/21/2018; LE/020918 Discard by 8/8/2017

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate matter