Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Fexofenadine Hydrochloride Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications
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
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
Affected NDCs
70677-0008-01
70677-0008-02
Compare with the code on your package — it is the most precise check available.
Drug: Fexofenadine Category: Allergy & Cold Medication
- Recalling firm
- Aurolife Pharma, LLC
- NDC code
- 70677-0008-2
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1868-2019 · 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
Class II · Moderate risk
Picnic
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Other recalls by Aurolife Pharma, LLC
All 2019 recalls
Class III · Low risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Tablets
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Class II · Moderate risk
Allergy (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
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