Class II · Moderate risk Terminated
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA…
Reason Lack of Processing Controls
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 II · Moderate risk Terminated
Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
Reason Lack of Processing Controls.
Class III · Low risk Terminated
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For…
Reason Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Class II · Moderate risk Ongoing
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only…
Reason Defective Delivery System: Elevated number of units with out of specification results for leak rate
Class II · Moderate risk Ongoing
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx…
Reason Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Class III · Low risk Terminated
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc…
Reason Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class II · Moderate risk Terminated
Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada…
Reason Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Class II · Moderate risk Terminated
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation…
Reason Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of…
Class II · Moderate risk Terminated
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30…
Reason Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Class II · Moderate risk Terminated
COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered…
Reason Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Class III · Low risk Terminated
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ…
Reason Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class II · Moderate risk Terminated
Levalbuterol 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 II · Moderate risk Terminated
Albuterol Sulfate 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 II · Moderate risk Terminated
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials…
Reason Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial…
Class II · Moderate risk Terminated
ALBUTEROL SULFATE ER, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378412201.
Reason Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet…
Class II · Moderate risk Terminated
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY -…
Reason Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Class II · Moderate risk Terminated
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials)…
Reason Lack of Assurance of Sterility
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