Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; ASPIRIN Tablet, 325 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002642, EXP: 6/4/2014.
ASPIRIN Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348000123
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: Observations were made that some blister card-foils were separating from the blister cavity.
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Reason Failed Tablet/Capsule Specification : Capsule breakage
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations
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