D-0850-2018 Class II Terminated

Recalled by RIJ Pharmaceutical LLC — Middletown, NY

Recall Details

Product Type
Drugs
Report Date
June 20, 2018
Initiation Date
May 7, 2018
Termination Date
April 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31411 bottles

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 47060011, 47070031, 47070041, Exp. 09/18; 47080031, Exp.10/18