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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Category
- Drug — Cough and Cold
- Hazard
- 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.
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