Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Affected NDC
42291-0297-50
Compare with the code on your package — it is the most precise check available.
Drug: Fexofenadine Category: Allergy & Cold Medication
- Recalling firm
- AVKARE Inc.
- NDC code
- 42291-297-50
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1875-2019 · 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
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Picnic
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Other recalls by AVKARE Inc.
All 2019 recalls
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
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Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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