Senna Syrup 8 recalled over manufacturing violations

Recall date

August 8, 2016

Source

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

Official notice title

Pharmatech LLC recalls Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Dri…

Recall number

D-1526-2016

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

Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.