Coastal Meds Recalls Hydroxocobalamin Injectable Due to Particulate Matter
Coastal Meds, LLC. is recalling 1,506 vials of Hydroxocobalamin Injectable due to the presence of unknown particulate matter. The product was distributed nationwide.
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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe; while specific injury reports are not detailed in the text, the Class II designation for a drug with particulate matter (a risk of serious harm) aligns with the Severe tier criteria for significant risk.
Plain-English summary
Coastal Meds, LLC. is recalling 1,506 vials of Hydroxocobalamin Injectable-30 mL MDV. The recall is being conducted because of the presence of unknown particulate matter in the product.
The affected lots are CAH/101617, H/120117, H/010518, H/020718, H/021518, and CAH/021218. These products were distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact Coastal Meds, LLC. for further instructions or a refund.
The recalled product
- Product
- HYDROXOCOBALAMIN 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
- 1,506
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: CAH/101617 Discard by 04/14/2018
- H/120117 Discard by 5/30/2018
- H/010518 Discard by 7/4/2018
- H/020718 Discard by 8/6/2018
- H/021518 Discard by 8/14/2018
- CAH/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 →Related recalls
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