SENNA Syrup
Reason Microbial Contamination of Non-Sterile Product
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: SENNOSIDES, Tablet, 8.6 mg may have potentially been mislabeled as one of the following drugs: FEXOFENADINE HCL, Tablet, 180 mg, NDC 41167412003, Pedigree: AD62834_1, EXP: 5/23/2014; TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: W002976, EXP: 6/11/2014; LORATADINE, Tablet, 10 mg, NDC 45802065078, Pedigree: W003253, EXP: 6/17/2014.
SENNOSIDES, Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182109301.
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 Microbial Contamination of Non-Sterile Product
Reason Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
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