Class III · Low risk Ongoing
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications
NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What was recalled
NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 68047-186-16
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0507-2021
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.
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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
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Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Ketotifen Fumarate 0.025 %
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Terminated
Clear Eyes
Reason Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
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