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Drug FDA Class II Completed Foreign material

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.

Coast Quality Pharmacy, LLC dba Anazao Health Published Jul 3, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Coast Quality Pharmacy, LLC dba Anazao Health or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Metal Particulate · primary

Affected products (1)

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.

9896 tablets

Lot codes: 240312JL-629220
Code info: Product lot: 240312JL-629220; Exp. 09/08/2024

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 24, 2024
  2. Published
    Jul 3, 2024
Recall number
D-0563-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.