Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth,
Summary
The FDA issued a Class II for Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Ta by Coast Quality Pharmacy, LLC dba Anazao Health. Reason: Presence of Foreign Substance; Broken metal piece found embedded in tablet..
Details
Source
Drug Recall
External ID
D-0563-2024
Action Date
2024-07-03
Status
Completed
Category
drug
Product Description
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.
Lot/Code Info: Product lot: 240312JL-629220; Exp. 09/08/2024
Quantity Affected: 9896 tablets
Reason for Recall
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-24
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Coast Quality Pharmacy, LLC dba Anazao Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Coast Quality Pharmacy, LLC dba Anazao Health have FDA actions?
This is the only FDA action we have on record for Coast Quality Pharmacy, LLC dba Anazao Health in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0563-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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