Aidarex Recalls Chlorhexidine Gluconate Oral Rinse Due to Impurity
Aidarex Pharmaceuticals is recalling 292 bottles of Chlorhexidine Gluconate 0.12% Oral Rinse because the product failed impurity specifications.
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 2/5 (Moderate).
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is an unknown impurity rather than a high-risk pathogen or structural defect.
Plain-English summary
Aidarex Pharmaceuticals LLC is recalling 292 bottles of Chlorhexidine Gluconate 0.12% Oral Rinse, packaged in 473 mL bottles. The product is prescription-only and was manufactured by Hi-Tech Pharmacal Co., Inc. The recall involves specific lots with expiration dates ranging from January 2017 to May 2017.
The recall was initiated because the product failed impurity/degradation specifications, specifically due to an out-of-specification unknown impurity. The affected product was distributed in the United States, including California, North Dakota, Pennsylvania, and Tennessee.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of or return the medication.
The recalled product
- Product
- CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Category
- Drug — Oral Rinse
- Hazard
- Affected units
- 292
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 (17)
- Lot #: 45335-1
- Expiry: 2017/02
- Lot #: 46807-1
- Expiry: 2017/01
- Lot #: 44359-1
- Lot #: 44395-1
- Lot #: 44693-1
- Lot #: 44694-1
- Lot #: 43707-1
- Expiry: 2017/03
- Lot #: 47697-1
- Lot #: 48605-1
- Lot #: 48659-1
- Lot #: 47772-1
- Expiry: 2017/05
- Lot #: 48271-1
- Expiry: 2017/05.
Distribution
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