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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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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