Class III · Low risk Ongoing
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications
Antihistamine & Nasal Decongestant
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed dissolution specifications
What was recalled
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- NDC code
- 0638-1242-07
- Origin
- NJ, United States
- Initiated by
- N/A
- FDA recall number
- D-0271-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Fexofenadine recalls
See all
Class II · Moderate risk Completed
Fexofenadine Hydrochloride Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Picnic
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
allergy relief
Reason Failed Impurities/Degradation Specifications
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