Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
CAREONE Allergy Relief (Fexofenadine HCL)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech Republic
Affected NDCs
41520-0229-39
41520-0229-95
Compare with the code on your package — it is the most precise check available.
Drug: Fexofenadine Category: Allergy & Cold Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| CareOne Allergy Relief fexofenadine hcl NDC 41520-0229 |
FEXOFENADINE HYDROCHLORIDE 180 mg/1 | Tablet, Film Coated Oral |
American Sales Company | OTC |
- Recalling firm
- Perrigo Company PLC
- NDC code
- 41520-229-39
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0334-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Picnic
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Other recalls by Perrigo Company PLC
All 2021 recalls
Class II · Moderate risk
Maximum Strength Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Maximum Strength Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Sinus Severe
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
No Drip Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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