Class II · Moderate risk Ongoing
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B…
Reason Labelling: Illegible label
Is Albuterol recalled?
47 FDA recalls mention Albuterol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Albuterol.
Class III · Low risk Ongoing
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore…
Reason Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the…
Class II · Moderate risk Ongoing
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC…
Reason Defective delivery system
Class II · Moderate risk Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton…
Reason Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class I · High risk Terminated
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only…
Reason Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class II · Moderate risk Ongoing
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations, Rx only, MFG: Merck Company, NDC 0085-1132-04
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered inhalations, Rx only, Manufactured for: PAR…
Reason cGMP deviations: Temperature abuse
Class III · Low risk Terminated
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03)…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG by: Nephron Pharma…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx only, MFG: Nephron…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions…
Reason Defective Delivery System: Sustained trend of failure to dispense complaints.
Class II · Moderate risk Terminated
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Reason Lack of Processing Controls
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