Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02
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 - products manufactured in a shared facility with Ezetimibe tablets.
Reason cGMP Deviations
Reason CGMP Deviations
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