Geritrex Recalls Diphenhydramine Oral Liquid Due to Potential Microbial Contamination
Geritrex, LLC is recalling 8,645 bottles of Diphenhydramine Oral Liquid 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 a risk of microbial contamination, which aligns with the rubric criteria for a Severe rating (Score 4) involving significant health risks.
Plain-English summary
Geritrex, LLC is voluntarily recalling 8,645 bottles of Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL). The product is manufactured by RIJ Pharmaceutical Corporation and is identified by NDC 53807-204-04, Lot # 70606, and an expiration date of 6/19.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. These deviations mean that the affected products may have microbial contamination. The recall is classified as FDA Class II.
The affected product was distributed nationwide in the United States. Consumers who have this product should stop using it and contact Geritrex, LLC for further instructions or a refund.
The recalled product
- Product
- Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04
- Manufacturer
- Geritrex, LLC
- Category
- Drug — Oral Liquid
- Hazard
- Affected units
- 8,645
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 #: 70606
- 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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