Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 50 mg may have potentially been mislabeled as one of the following drugs: ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: AD21811_10, EXP: 5/2/2014; LIOTHYRONINE SODIUM, Tablet, 5 mcg, NDC 42794001802, Pedigree: AD46414_38, EXP: 5/16/2014.
NORTRIPTYLINE HCL, Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093081201.
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: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Reason CGMP deviations.
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Reason Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 75 mg may have potentially been mislabeled as one of the following drugs: guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD21790_58, EXP: 5/1/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141509, Pedigree: W003693, EXP: 4/30/2014.
Reason Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 10 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD70585_1, EXP: 5/29/2014.
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