AAA Pharmaceutical Recalls Fexofenadine Tablets for Labeling Errors
AAA Pharmaceutical, Inc. is recalling specific lots of Discount Drug Mart Fexofenadine Hydrochloride Tablets due to incorrect or missing lot and expiration dates.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall for labeling errors (incorrect or missing lot/expiration dates), which the rubric defines as typically resulting in a score of 1 or 2 because they are unlikely to cause adverse health consequences.
Plain-English summary
AAA Pharmaceutical, Inc. is recalling 3,456 bottles of Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg. The affected products include 30-tablet bottles (NDC 53943-192-04) and 45-tablet bottles (NDC 53943-192-06). The recall covers Lot # P138855 and Lot # P138856, both with an expiration date of 05/30/2022.
The recall was initiated because the products have incorrect or missing lot and/or expiration dates on the labeling. The FDA has classified this as a Class III recall, which indicates that the labeling error is unlikely to cause adverse health consequences.
The affected products were distributed in Ohio. Consumers who have these specific products should stop using them and contact the recalling firm or their pharmacist for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3…
- Manufacturer
- AAA Pharmaceutical, Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 3,456
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 (3)
- Lot #s: a) P138855
- Exp. 05/30/2022
- b) P138856
Distribution
Distributed in 1 state:
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