FDA recall D-0696-2021

API Solutions Inc. · Class II · drug

Product

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

Reason for recall

cGMP Deviations

Distribution

AL, AZ, CO, FL, VA

Key facts

Status
Terminated
Initiation date
2021-07-15
Report date
2021-08-04
Termination date
2022-02-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Daphne, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0696-2021