Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures
Aurolife Pharma is recalling 4,536 cartons 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 recall is classified as FDA Class II, which corresponds to a severity score of 4 (Severe) according to the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Aurolife Pharma, LLC is recalling 4,536 cartons of Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count. The product is distributed by Discount Drug Mart in Medina, Ohio, and was available nationwide in the United States. The specific lot number is 067180024B1, with an expiration date of 07/21.
The recall was initiated because the product failed impurities and degradation specifications. This FDA Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased this specific lot of medication should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.
- Manufacturer
- Aurolife Pharma, LLC
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 4,536
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 #: 067180024B1
- 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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