Class III · Low risk Ongoing
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc…
Reason Failed Impurities/Degradation Specifications
Is Histamine recalled?
109 FDA recalls mention Histamine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Histamine.
Class II · Moderate risk Completed
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30…
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 (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer…
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack…
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Class II · Moderate risk Terminated
Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL…
Reason Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Class II · Moderate risk Terminated
Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy…
Reason Lack of sterility assurance
Class III · Low risk Terminated
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets…
Reason Failed dissolution specifications
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by…
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by…
Reason CGMP Deviations:
Class II · Moderate risk Terminated
Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk Terminated
Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile…
Reason CGMP Deviations: products were stored outside the drug label specifications.
Class III · Low risk Terminated
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a)…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20…
Reason Failed dissolution specifications
Class III · Low risk Terminated
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy…
Reason Failed dissolution specifications
Class III · Low risk Terminated
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy…
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0…
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech…
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech…
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
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