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Recall Observatory FDA recall evidence

Drug product

Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.

D-0563-2024

April 24, 2024

Class II

Product summary

Firm
Coast Quality Pharmacy, LLC dba Anazao Health
Event
Event 94691
Status
Completed
Classification
Class II
Quantity
9896 tablets
Official record key
drug-enforcement:D-0563-2024

Official wording

Reason: Presence of Foreign Substance; Broken metal piece found embedded in tablet.

Code information: Product lot: 240312JL-629220; Exp. 09/08/2024

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance