SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC…
Reason Microbial Contamination of Non-Sterile Product
17 FDA recalls mention Sennosides. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sennosides.
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.
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.
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
Reason Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason Labeling: Label Mixup: SENNOSIDES, Tablet, 8.6 mg may have potentially been mislabeled as one of the following drugs: FEXOFENADINE HCL, Tablet, 180…
Reason Labeling:Label Mixup; SENNOSIDES Tablet, 8.6 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007…
Reason Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
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