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Recall Observatory FDA recall evidence

Drug product

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

D-0725-2018

April 05, 2018

Class II

Product summary

Firm
Coastal Meds, LLC.
Event
Event 79671
Status
Terminated
Classification
Class II
Quantity
4524 vials
Official record key
drug-enforcement:D-0725-2018

Official wording

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

Code information: 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 pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate matter