PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 20, 2018 Initiated: May 7, 2018 #D-0842-2018

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.

Details

Recalling Firm
RIJ Pharmaceutical LLC
Units Affected
5043 bottles
Distribution
Nationwide in the USA
Location
Middletown, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by RIJ Pharmaceutical LLC. Units affected: 5043 bottles.
Why was this product recalled?
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 20, 2018. Severity: Moderate. Recall number: D-0842-2018.