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Recall Observatory FDA recall evidence

Drug product

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

D-0723-2018

April 05, 2018

Class II

Product summary

Firm
Coastal Meds, LLC.
Event
Event 79671
Status
Terminated
Classification
Class II
Quantity
1457 vials
Official record key
drug-enforcement:D-0723-2018

Official wording

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

Code information: 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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate matter