Fexofenadine Tablets Recalled for Failed Impurity and Degradation Specifications
L. Perrigo Company is recalling Picnic Fexofenadine Hydrochloride Tablets (180 mg) nationwide because the product failed impurity and degradation specifications. The affected lot is 2DR0471 with expiration date 12/23.
What this means for you
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 for failed pharmaceutical quality specifications (impurities and degradation). No illnesses or injuries reported. Per rubric criteria, recalls of this classification without reported harm but with significant quality control failures receive a High (3) rating.
Plain-English summary
L. Perrigo Company is recalling Picnic Fexofenadine Hydrochloride Tablets, 180 mg, an over-the-counter antihistamine medication distributed by Thirty Madison, Inc. The recall was initiated because the product failed to meet FDA impurity and degradation specifications.
When a pharmaceutical product fails these specifications, it may contain unexpected impurities or has degraded beyond acceptable standards. This affects the product's safety and effectiveness. The recalled product is identified by Lot 2DR0471 with an expiration date of December 2023.
The recall affects approximately 6,216 cartons that were distributed nationwide within the United States. Consumers who have purchased this specific lot should stop using the product and consult their pharmacist or healthcare provider about alternative medications or proper disposal.
The recalled product
- Product
- Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03
- Manufacturer
- L. Perrigo Company
- Category
- Drug — Antihistamine
- Hazard
- impurities
- degradation
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#: 2DR0471
- Exp. Date 12/23
Distribution
Distributed nationwide across the United States.
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