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Recall Observatory FDA recall evidence

Drug product

HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

D-0719-2018

April 05, 2018

Class II

Product summary

Firm
Coastal Meds, LLC.
Event
Event 79671
Status
Terminated
Classification
Class II
Quantity
1506 vials
Official record key
drug-enforcement:D-0719-2018

Official wording

Reason: Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Code information: 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 pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate matter