Sennazon Syrup recalled over manufacturing violations

Recall date

August 8, 2016

Source

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

Official notice title

Pharmatech LLC recalls Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, N…

Recall number

D-1520-2016

FDA classification

Class II

Brand / firm

Pharmatech LLC

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

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

What was recalled

Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.