Class II · Moderate risk Ongoing
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9…
Reason Lack of Assurance of Sterility
Is Azelastine recalled?
9 FDA recalls mention Azelastine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Azelastine.
Class II · Moderate risk Ongoing
Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net…
Reason Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class III · Low risk Terminated
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc…
Reason Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Class II · Moderate risk Terminated
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net…
Reason Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class III · Low risk Terminated
Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind…
Reason Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for…
Class III · Low risk Terminated
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed…
Reason Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Class II · Moderate risk Terminated
Azelastine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class III · Low risk Terminated
Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto…
Reason CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.