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Recall Observatory FDA recall evidence

Drug product

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

D-0720-2018

April 05, 2018

Class II

Product summary

Firm
Coastal Meds, LLC.
Event
Event 79671
Status
Terminated
Classification
Class II
Quantity
3959 vials
Official record key
drug-enforcement:D-0720-2018

Official wording

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

Code information: Lots: LB/100517 Discard by 4/3/2018; LB/111717 Discard by 5/16/2018; LB/120717 Discard by 6/5/2018; LB/010418 Discard by 7/3/2018; LB/012618 Discard by 7/25/2018; LB/022118 Discard by 8/20/2018; CALB/012918 Discard by 3/30/2018; CALB/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