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.
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 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
- Affected units
- 6,216
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.
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
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