Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534…
Reason CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; ZONISAMIDE Capsule, 100 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003737, EXP: 5/31/2014.
ZONISAMIDE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679099001
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 CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
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