Class II · Moderate risk Terminated
Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Remeven Cream
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Crystallization; Complaints that cream appears to have crystallized
What was recalled
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.
- Recalling firm
- Stratus Pharmaceuticals Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1464-2016
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.
Other Urea recalls
See all
Class II · Moderate risk Terminated
ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic…
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
ZTE-105 Formula Gentle Detoxing. Contents 1000 mL
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
StellaLife VEGA Oral Gel Rinse
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
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