Coastal Meds Recalls Methylcobalamin Injectable Due to Particulate Matter
Coastal Meds, LLC. is recalling 4,524 vials of Methylcobalamin Injectable 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (injection with particulate matter) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Coastal Meds, LLC. is recalling 4,524 vials of Methylcobalamin Injectable-30 mL. The recall is being conducted because of the presence of unknown particulate matter in the product.
The affected lots were distributed nationwide in the USA. The specific lot numbers and discard dates are: MC/102017 (Discard by 4/18/2018), MC/110217 (Discard by 5/1/2018), MC/120517 (Discard by 6/3/2018), MC/122117 (Discard by 6/19/2018), MC011718 (Discard by 7/16/2018), MC/012418 (Discard by 7/23/2018), MC/022018 (Discard by 8/19/2018), MC/021518 (Discard by 4/16/2018), and CAMC/013018 (Discard by 3/31/2018).
Consumers and healthcare providers should stop using the affected product and contact Coastal Meds, LLC. for further instructions.
The recalled product
- Product
- METHYLCOBALAMIN 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
- 4,524
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 (9)
- Lots: MC/102017 Discard by 4/18/2018
- MC/110217 Discard by 5/1/2018
- MC/120517 Discard by 6/3/2018
- MC/122117 Discard by 6/19/2018
- MC011718 Discard by 7/16/2018
- MC/012418 Discard by 7/23/2018
- MC/022018 Discard by 8/19/2018
- MC/021518 Discard by 4/16/2018
- CAMC/013018 Discard by 3/31/2018
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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