PlainRecalls
FDA Drug Moderate Class II Terminated

Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088

Reported: June 20, 2018 Initiated: May 7, 2018 #D-0850-2018

Product Description

Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088

Reason for Recall

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

Details

Recalling Firm
RIJ Pharmaceutical LLC
Units Affected
31411 bottles
Distribution
Nationwide in the USA
Location
Middletown, NY

Frequently Asked Questions

What product was recalled?
Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088. Recalled by RIJ Pharmaceutical LLC. Units affected: 31411 bottles.
Why was this product recalled?
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 20, 2018. Severity: Moderate. Recall number: D-0850-2018.