Drug recall D-0851-2018

Class II Terminated reported Jun 20, 2018

Product

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

Reason for recall

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

Lots and codes

Lot #: 47070042, Exp. 09/18

Recall details

Recalling firm
RIJ Pharmaceutical LLC, Middletown, NY
Quantity
3537 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
May 7, 2018
Terminated
April 7, 2023

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