Class I · High risk Terminated
SENNA Syrup
Reason Microbial Contamination of Non-Sterile Product
SDA Senna Syrup
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
What was recalled
SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082
- Recalling firm
- RIJ Pharmaceutical LLC
- NDC code
- 66424-562-08
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0851-2018
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
Geritrex 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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