Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD60211_1, EXP: 5/21/2014; MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, Pedigree: AD62865_7, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD65457_10, EXP: 5/24/2014.
DOCUSATE SODIUM, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 67618010060
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 CGMP Deviations
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Reason cGMP Deviations: Products may have microbial contamination.
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