The Recall Desk
ModerateFDA (Drugs)·D-0843-2018·Announced 2018-06-20

RIJ Pharmaceutical Recalls Preferred Plus Pharmacy Antacid Due to Microbial Count

RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid because a water sample used in manufacturing showed an out-of-specification total aerobic microbial count.

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 severity voluntary precautionary recall without reported illnesses.

Plain-English summary

RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg, Simethicone 20mg) in 12 FL. OZ. (355 mL) bottles. The product is manufactured by RIJ Pharmaceutical Corporation and distributed by Kinray Inc. The recall involves specific lots: 707006 (Exp. 07/19) and 708001 (Exp. 08/19). The product was distributed nationwide in the USA.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an out-of-specification total aerobic microbial count was detected in a water sample. This indicates a potential quality control issue in the manufacturing process.

Consumers who have this product should check their bottles for the lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact the distributor or manufacturer for instructions on return or disposal.

The recalled product

Product
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

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 (4)

  • Lot #: 707006
  • Exp. 07/19
  • 708001
  • Exp. 08/19

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 →