Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
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 Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Reason cGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
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