The Recall Desk
SevereFDA (Drugs)·D-0719-2018·Announced 2018-05-02

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.

What this means for you

Illness, injury, or structural failure has been reported. 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

Same manufacturer · Coastal Meds, LLC.

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Same hazard · particulate matter

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