Aurolife Recalls Fexofenadine Tablets Due to Impurity Failures
Aurolife Pharma is recalling equate Allergy Relief 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 classification is FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving specification failures.
Plain-English summary
Aurolife Pharma, LLC is recalling equate Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons. The recall involves 129,600 cartons distributed nationwide in the USA by Wal-Mart Stores, Inc.
The recall was initiated because the product failed impurities and degradation specifications. The affected lots are 067180010A (Exp 03/21), 067180023C1, and 067180024D1 (Exp 07/21). The NDC for the product is 49035-995-62.
Consumers who have purchased these specific lots should stop using the product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.
- Manufacturer
- Aurolife Pharma, LLC
- Hazard
- Affected units
- 129,600
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 (5)
- Lot #s: 067180010A
- Exp 03/21
- 067180023C1
- 067180024D1
- 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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