D-0842-2018 Class II Terminated

Recalled by RIJ Pharmaceutical LLC — Middletown, NY

Recall Details

Product Type
Drugs
Report Date
June 20, 2018
Initiation Date
May 7, 2018
Termination Date
April 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5043 bottles

Product Description

Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC 353807158123

Reason for Recall

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 707007, Exp. 07/19