Class I · High risk
SENNA Syrup
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
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
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
Affected NDCs
0536-1000-59
0904-6289-09
Compare with the code on your package — it is the most precise check available.
Drug: Sennosides
- Recalling firm
- Pharmatech LLC
- NDC code
- 0536-1000-59
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0226-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 III · Low risk
Sankaijo BOTANICAL LAXATIVE
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
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.
Other recalls by Pharmatech LLC
All 2017 recalls
Class II · Moderate risk
Rugby Aller-chlor
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Diocto Syrup
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Rugby Diocto Liquid
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk
Senna Syrup
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
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