Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: CLINDAMYCIN HCL, Capsule, 300 mg may have potentially been mislabeled as the following drug: MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD68019_7, EXP: 5/28/2014.
CLINDAMYCIN HCL, Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591312001.
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
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.