Class III · Low risk
Sankaijo BOTANICAL LAXATIVE
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
SENNA Syrup
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Product
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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.
Affected NDC
50262-0731-24
Compare with the code on your package — it is the most precise check available.
Drug: Sennosides
- Recalling firm
- Lohxa, LLC
- NDC code
- 50262-731-24
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0377-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Sennosides recalls
See all
Class II · Moderate risk
Senna (sennosides 8.8 mg)
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk
Senna (sennosides 8.8 mg)
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk
SDA Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Geritrex Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Other recalls by Lohxa, LLC
All 2021 recalls
Class I · High risk
Chlorhexidine Gluconate Oral Rinse USP
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Class II · Moderate risk
Phenobarbital Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk
Bismuth Subsalicylate Oral Suspension 262mg/15mL
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
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