Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
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 Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Reason cGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
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