RPC 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 RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial…

Recall number

D-0844-2018

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

RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080