April 2024 FDA Recall Drug by Coast Quality Pharmacy, Llc Dba Anazao Health
D-0563-2024 - Presence of Foreign Substance; Broken metal piece found embedded in tablet.

This Class II drug recall was voluntarily initiated by Coast Quality Pharmacy, Llc Dba Anazao Health on April 24, 2024 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; broken metal piece found embedded in tablet.. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0563-2024

Reason for Recall
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Initiated
04-24-2024
Reported
07-03-2024
Quantity
9896 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94691
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Coast Quality Pharmacy, LLC dba Anazao Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Product lot: 240312JL-629220; Exp. 09/08/2024