Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Discount Drug Mart
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Expiration date.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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, Distributed by: Drug Mart -Food Fair, 211 Commerce Drive, Medina, OH 44256.
Affected NDCs
53943-0192-04
53943-0192-06
Compare with the code on your package — it is the most precise check available.
Drug: Fexofenadine Category: Allergy & Cold Medication
- Recalling firm
- AAA Pharmaceutical, Inc.
- NDC code
- 53943-192-04
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0868-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fexofenadine recalls
See all
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
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Picnic
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Other recalls by AAA Pharmaceutical, Inc.
All 2020 recalls
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class III · Low risk
Smart Sense Regular Strength Aspirin Tablets
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
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