FDA Recalls Lipoderm Extreme Injectable Due to Particulate Matter
Coastal Meds, LLC. is recalling 3,733 vials of LIPO-DEN EXTREME Injectable-30 mL 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 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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk contamination.
Plain-English summary
Coastal Meds, LLC. is recalling 3,733 vials of LIPO-DEN EXTREME Injectable-30 mL. The recall was initiated because of the presence of unknown particulate matter in the product.
The affected product is distributed nationwide in the USA. The recall covers specific lots with discard dates ranging from April 17, 2018, to August 8, 2017. The lots involved are LE/101917, LE/110317, LE/110917, LE/010318, LE/012218, and LE/020918.
Consumers and healthcare providers should stop using the affected product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- LIPO-DEN EXTREME 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
- 3,733
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: LE/101917 Discard by 4/17/2018
- LE/110317 Discard by 5/2/2018
- LE/110917 Discard by 5/8/2018
- LE/010318 Discard by 7/2/2018
- LE/012218 Discard by 7/21/2018
- LE/020918 Discard by 8/8/2017
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
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