Aurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures
Aurolife Pharma is recalling 240 bottles of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation 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 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 agency classified this as an FDA Class II recall. Per the rubric, an FDA Class II recall involving a structural or quality defect in a drug product is assigned a severity score of 4 (Severe).
Plain-English summary
Aurolife Pharma, LLC is recalling 240 bottles of Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles. The product is distributed by Aurohealth LLC and carries the NDC 58602-820-09. The specific lot affected is 067180026A1, with an expiration date of 07/21.
The recall was initiated because the product failed impurities and degradation specifications. This indicates that the tablets did not meet the required quality standards regarding chemical purity and stability.
The affected product was distributed nationwide in the USA. Consumers who have this specific lot of medication should stop using it and contact their pharmacist or healthcare provider for guidance on returning the product or obtaining a replacement.
The recalled product
- Product
- Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.
- Manufacturer
- Aurolife Pharma, LLC
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 240
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 #: 067180026A1
- Exp 07/21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Aurolife Pharma, 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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