Drug & medication recalls Moderate risk

GeriCare 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 GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street…
Recall number
D-0848-2018
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

GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087

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