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Recall Observatory FDA recall evidence

Drug product

Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00

D-0810-2018

April 10, 2018

Class III

Product summary

Firm
Aidarex Pharmaceuticals LLC
Event
Event 79835
Status
Terminated
Classification
Class III
Quantity
450 bottles
Official record key
drug-enforcement:D-0810-2018

Official wording

Reason: Presence of Foreign Tablets/Capsules

Code information: NDC 33261-0715-00 Batch ID: 57909-1, exp. date 04/30/2019 57909-2, exp. date 06/30/2019

Distribution pattern: Product was distributed to Florida

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets