The Recall Desk
SevereFDA (Drugs)·D-0723-2018·Announced 2018-05-02

Coastal Meds Recalls LIPO-DEN PLUS Injectable Due to Particulate Matter

Coastal Meds, LLC. is recalling 1,457 vials of LIPO-DEN PLUS Injectable because of the presence of unknown particulate matter. The product was distributed nationwide in the USA.

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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving injectable products where particulate matter poses a significant risk of harm.

Plain-English summary

Coastal Meds, LLC. is recalling 1,457 vials of LIPO-DEN PLUS Injectable-30 mL. The recall was initiated due to the presence of unknown particulate matter in the product.

The affected lots include LDP/100317, LDP/011618, CALDP/020118, CALDP/012918, and CALDP/021518. These products were distributed nationwide in the USA. The source text does not specify the number of reported illnesses or injuries associated with this recall.

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-DEN PLUS 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
1,457

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 (5)

  • 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

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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