Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: AD65475_13, EXP: 5/28/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD68025_1, EXP: 5/28/2014; PANTOPRAZOLE SODIUM DR, Tablet, 40 mg, NDC 64679043402, Pedigree: AD37063_10, EXP: 5/13/2014; DOCUSATE SODIUM
DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904789159
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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