FDA recall D-0842-2018

Product

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

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-05-07

Report date

2018-06-20

Termination date

2023-04-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Middletown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0842-2018