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Recall Observatory FDA recall evidence

Drug product

Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

D-1260-2014

March 17, 2014

Class II

Product summary

Firm
John W Hollis Inc
Event
Event 67812
Status
Terminated
Classification
Class II
Quantity
3 vials
Official record key
drug-enforcement:D-1260-2014

Official wording

Reason: Presence of Particulate Matter

Code information: Lot #: 641:07, Expiry: 8/11/14

Distribution pattern: MO, TN, MS, WI

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter