Careone Allergy Relief tablets recalled for failed impurity and degradation specifications
Careone Allergy Relief fexofenadine hydrochloride 180mg tablets are recalled nationwide for failing impurity and degradation specifications. Lot 2JE2185 with expiration date 01/24 is affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving failed pharmaceutical quality specifications (impurities and degradation) constitutes a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for severity score 3.
Plain-English summary
Careone Allergy Relief fexofenadine hydrochloride 180mg tablets are being recalled due to failed impurity and degradation testing specifications. The affected product is a 15-count carton distributed by Adusa Distribution, LLC in Salisbury, North Carolina.
The manufacturer, L. Perrigo Company, initiated this recall after determining that certain lots failed to meet established specifications for impurities and product degradation. This is classified as a Class II recall by the FDA.
The recall affects 3,240 cartons distributed nationwide within the United States. Lot 2JE2185 with expiration date 01/24 is specifically identified as part of this recall.
The recalled product
- Product
- CAREONE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
- Brand
- CAREONE ALLERGY RELIEF
- Manufacturer
- L. Perrigo Company
- Category
- Drug
- Hazard
- Affected units
- 3,240
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 #: 2JE2185
- Exp. date 01/24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by L. Perrigo Company 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.
See all 13 products in this recall →Related recalls
Same brand · CAREONE ALLERGY RELIEF
- ModerateCAREONE Allergy Relief 180 mg Tablets Recalled for Failed Impurities Specifications
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Similar recalls
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FDA (Drugs) · 2022-01-12
- ModerateAurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures
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