Coastal Meds Recalls ADENO-PLEX Injectable Due to Particulate Matter
Coastal Meds, LLC. is recalling 200 vials of ADENO-PLEX Injectable-30 mL MDV 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 agency classification is FDA Class II, and the presence of unknown particulate matter in an injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Coastal Meds, LLC. is recalling 200 vials of ADENO-PLEX Injectable-30 mL MDV. The recall is being conducted because of the presence of unknown particulate matter in the product.
The affected product is identified by Lot AP/011218 with a discard by date of 7/11/2018. The product was distributed nationwide in the USA.
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
- ADENO-PLEX 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
- 200
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 (1)
- Lot: AP/011218 Discard by 7/11/2018
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
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