The Recall Desk
SevereFDA (Drugs)·D-0724-2018·Announced 2018-05-02

Coastal Meds Recalls LIPO-PLEX Injectable Due to Particulate Matter

Coastal Meds, LLC. is recalling LIPO-PLEX Injectable-30 mL vials nationwide due to the presence of unknown particulate matter.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of injecting unknown particulate matter.

Plain-English summary

Coastal Meds, LLC. is voluntarily recalling 8,099 vials of LIPO-PLEX Injectable-30 mL. The recall is being conducted because of the presence of unknown particulate matter in the product.

The affected product was distributed nationwide in the USA. The recall covers specific lots with discard dates ranging from April 4, 2018, to August 15, 2018, as well as one lot with a discard date of April 13, 2018.

Consumers and healthcare providers should stop using the affected vials and contact Coastal Meds, LLC. for further instructions or a refund.

The recalled product

Product
LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Manufacturer
Coastal Meds, LLC.
Category
Drug — Injectable
Hazard
Affected units
8,099

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 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

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Coastal Meds, LLC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Related recalls

Same manufacturer · Coastal Meds, LLC.

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Same hazard · particulate matter

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