Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals
Summary
The FDA issued a Class II for Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Ala by API Solutions Inc.. Reason: cGMP Deviations.
Details
Source
Drug Recall
External ID
D-0696-2021
Action Date
2021-08-04
Status
Terminated
Category
drug
Product Description
Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York
Lot/Code Info: Lot #: AZA181105, Exp 11/09/2021
Quantity Affected: 1 bottle
Reason for Recall
cGMP Deviations
Distribution
AL, AZ, CO, FL, VA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-15
Company
Daphne, AL
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 48 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
API Solutions Inc. has 2 FDA actions in our database, including 2 recalls.
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 (API Solutions Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does API Solutions Inc. have FDA actions?
API Solutions Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0696-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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