Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904549213, Pedigree: AD23082_13, EXP: 11/1/2013; PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: W003682, EXP: 6/25/2014.
PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009190
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 Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
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