Class III · Low risk Ongoing
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications
Is Histamine recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Histamine (109 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Histamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
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
Safe Tussin PM Night Time Cough Relief
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.
Class II · Moderate risk Terminated
Picnic
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Diphenhydramine 18mg in 3.6ML NS SYRINGE
Reason Lack of sterility assurance
Class III · Low risk Terminated
Allergy Relief D
Reason Failed dissolution specifications
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCL Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Terminated
Pataday
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Systane Zaditor
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Naphcon A eye drops
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class III · Low risk Terminated
Leader
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
CVS Health
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
equate
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Kroger
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Rugby
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Wal-Fex D
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
12 HR Allergy & Congestion Relief Fexofenadine HCl
Reason Failed dissolution specifications
Class III · Low risk Terminated
Antihistamine & Nasal Decongestant
Reason Failed dissolution specifications
Class III · Low risk Terminated
Antihistamine & Nasal Decongestant
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
CVS Allergy Relief
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
Kirkland Aller-Fex
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
amazon basic+care
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
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