Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD65457_19, EXP: 5/24/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD56924_1, EXP: 5/21/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: W003257, EXP: 6/17/2014.
DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00173071204.
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 Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
Reason Lack of assurance of sterility
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