Class I — High risk. Reasonable probability of serious harm or death.
Microbial Contamination of Non-Sterile Product
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
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: 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.
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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