CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR recall — FDA D-0334-2022
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Complete FDA and NHTSA recall records dated in 2022, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Out-of-specification impurity test result observed at 18-month long term stability time point.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent…
To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters…
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the…
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.