FDA-Drug2018-06-20Class II

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

RIJ Pharmaceutical LLC
Hazard

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

Sold states
Nationwide in the USA
Affected count
5043 bottles
Manufactured in
40 Commercial Ave, N/A, Middletown, NY, United States
Products
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

Official notice

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

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