PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 20, 2018 Initiated: May 7, 2018 #D-0843-2018

Product Description

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

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
N/A
Distribution
Nationwide in the USA
Location
Middletown, NY

Frequently Asked Questions

What product 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. Recalled by RIJ Pharmaceutical LLC. Units affected: N/A.
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-0843-2018.