The Recall Desk
SevereFDA (Drugs)·D-1521-2019·Announced 2019-07-31

Geritrex Recalls Ritussin DM Due to Potential Microbial Contamination

Geritrex, LLC is recalling 5,107 bottles of Ritussin DM Children & Adults due to cGMP deviations that may result in microbial contamination.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that products may have microbial contamination, which aligns with the rubric criteria for Severe severity involving significant health risks.

Plain-English summary

Geritrex, LLC is voluntarily recalling 5,107 bottles of Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), NDC 53807-409-04. The recall is being conducted due to Current Good Manufacturing Practice (cGMP) deviations that may have resulted in microbial contamination of the product.

The affected product is identified by Lot # 70602 and an expiration date of 6/19. The recall covers distribution across the United States nationwide.

Consumers who have purchased this product should stop using it and contact Geritrex, LLC or their healthcare provider for further instructions.

The recalled product

Product
Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04
Manufacturer
Geritrex, LLC
Affected units
5,107

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 #: 70602
  • Exp 6/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Geritrex, 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 8 products in this recall →