FDA-Drug2018-06-20Class II

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

RIJ Pharmaceutical LLC
Hazard

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

Sold states
Nationwide in the USA
Affected count
3537 bottles
Manufactured in
40 Commercial Ave, N/A, Middletown, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0851-2018

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