The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0721-2018·Announced 2018-05-02

FDA Recalls LIPO-DEN Injectable Due to Unknown Particulate Matter

Coastal Meds, LLC. is recalling 1,309 vials of LIPO-DEN Injectable-30 mL because of the presence of unknown particulate matter.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves unknown particulate matter in an injectable drug, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for significant potential harm without confirmed fatalities or Class I classification.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for LIPO-DEN Injectable-30 mL manufactured by Coastal Meds, LLC. The recall involves 1,309 vials distributed nationwide in the USA. The specific reason for the recall is the presence of unknown particulate matter in the product.

The affected lots are LD/120417 (Discard by 6/2/2018), LD/122017 (Discard by 6/18/2018), LD/011618 (Discard by 7/15/2018), CALD/013118 (Discard by 4/1/2018), CALD/020518 (Discard by 4/6/2018), and CALD/021418 (Discard by 4/15/2018). The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected vials immediately. The source text does not specify further instructions for disposal or return, but the presence of particulate matter in an injectable product poses a risk of adverse health effects if administered.

The recalled product

Product
LIPO-DEN 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
1,309

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 (6)

  • Lots: LD/120417 Discard by 6/2/2018
  • LD/122017 Discard by 6/18/2018
  • LD/011618 Discard by 7/15/2018
  • CALD/013118 Discard by 4/1/2018
  • CALD/020518 Discard by 4/6/2018
  • CALD/021418 Discard by 4/15/2018

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 →

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