The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0720-2018·Announced 2018-05-02

Coastal Meds Recalls LIPO-B Injectable Due to Particulate Matter

Coastal Meds, LLC. is recalling LIPO-B Injectable-30 mL vials due to 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, and the presence of unknown particulate matter in an injectable drug represents a risk of harm where injury has not yet been reported.

Plain-English summary

Coastal Meds, LLC. is recalling 3,959 vials of LIPO-B Injectable-30 mL. The recall is being conducted because of the presence of unknown particulate matter in the product.

The affected lots were distributed nationwide in the USA. The specific lot numbers and discard dates are: 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), and CALB/021218 (Discard by 4/13/2018).

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

The recalled product

Product
LIPO-B 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
3,959

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 (8)

  • 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

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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