Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Crystallization; complaints received by the manufacturer of crystals forming in product
Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY
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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