Preferred Plus Pharmacy Antacid bottles 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 Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 F…

Recall number

D-0843-2018

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

Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357, NDC 53807-12612, UPC 53807126122