Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: DOCUSATE CALCIUM, Capsule, 240 mg may have potentially been mislabeled as one of the following drugs: diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD33897_13, EXP: 5/9/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD49610_1, EXP: 5/16/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W002775, EXP: 6/6/2014; VITAMIN B
DOCUSATE CALCIUM, Capsule, 240 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375501.
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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