Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Geritrex, LLC

NDC code

53807-556-08

Origin

NY, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-1436-2019

Other Sennosides recalls

See all

Class I · High risk Terminated Dec 21, 2021

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

Lohxa, LLC NDC 50262-731-24 D-0377-2022

Class III · Low risk Terminated Oct 1, 2019

Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO…

Reason Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.

Sato Pharmaceutical Inc. NDC 49873-404-01 D-0303-2020

Class II · Moderate risk Terminated May 6, 2019

Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY…

Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Geritrex, LLC NDC 54162-007-08 D-1437-2019

Class II · Moderate risk Terminated May 7, 2018

SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 66424-562-08 D-0851-2018

Class II · Moderate risk Terminated May 7, 2018

Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 54162-007-08 D-0850-2018