Gericare Geri-Tussin DM Recalled for Potential Microbial Contamination
Geritrex, LLC is recalling Gericare Geri-Tussin DM 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 involves potential microbial contamination, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant health impact).
Plain-English summary
Geritrex, LLC is voluntarily recalling 6,213 bottles of Gericare Geri-Tussin DM, 16 FL OZ (473 mL), NDC 57896-660-16. 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 this product should stop using it and contact Geritrex, LLC for further instructions or a refund.
The recalled product
- Product
- Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16
- Manufacturer
- Geritrex, LLC
- Category
- Drug — Cough and Cold
- Hazard
- Affected units
- 6,213
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 →Related recalls
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