FDA Drug Recalls

Recalls / Class II

Class IID-0563-2024

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.

Affected lot / code info
Product lot: 240312JL-629220; Exp. 09/08/2024

Why it was recalled

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

Recalling firm

Firm
Coast Quality Pharmacy, LLC dba Anazao Health
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
5710 Hoover Blvd, Tampa, Florida 33634-5339

Distribution

Quantity
9896 tablets
Distribution pattern
U.S. Nationwide

Timeline

Recall initiated
2024-04-24
FDA classified
2024-06-22
Posted by FDA
2024-07-03
Status
Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0563-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.