The Recall Desk
ModerateFDA (Drugs)·D-0842-2018·Announced 2018-06-20

RIJ Pharmaceutical Recalls Antacid Due to Microbial Count Deviation

RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid Extra Strength due to out-of-specification microbial counts in a water sample.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a CGMP deviation regarding microbial counts in a water sample, which fits the criteria for a moderate risk or voluntary precautionary recall without reported illness.

Plain-English summary

RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg) in 12 FL. OZ. (355 mL) bottles. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically an out-of-specification total aerobic microbial count detected in a water sample.

The affected product is identified by Lot # 707007 and an expiration date of 07/19. The product was distributed nationwide in the USA. The recall involves 5,043 bottles.

Consumers who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on disposal or return.

The recalled product

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,
Affected units
5,043

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 707007
  • Exp. 07/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by RIJ Pharmaceutical LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →