Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Crystallization; Complaints that cream appears to have crystallized
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
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