Class I · High risk Terminated
SENNA Syrup
Reason Microbial Contamination of Non-Sterile Product
Rugby Senexon Liquid Natural Vegetable Stimulant
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
What was recalled
Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09; Manufactured by PharmaTech LLC, Davie, FL
- Recalling firm
- Pharmatech LLC
- NDC code
- 0536-1000-59
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0226-2018
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.
Other Sennosides recalls
See all
Class III · Low risk Terminated
Sankaijo BOTANICAL LAXATIVE
Reason Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class II · Moderate risk Terminated
Senna
Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk Terminated
Senna
Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk Terminated
SDA Senna Syrup
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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