SDA Senna Syrup recalled over manufacturing violations

Recall date

May 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

RIJ Pharmaceutical LLC recalls SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroa…

Recall number

D-0851-2018

FDA classification

Class II

Brand / firm

RIJ Pharmaceutical LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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