Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; clomiPRAMINE HCl Capsule, 50 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46265_25, EXP: 5/15/2014; CHLORTHALIDONE, Tablet, 50 mg, NDC 00378021301, Pedigree: W002988, EXP: 6/11/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W003674, EXP: 6/25/2014; ISOSORBIDE MONONITRATE, Tablet, 10 mg, NDC 6217501060
clomiPRAMINE HCl Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401205
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: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Reason cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Reason Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Reason Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
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