Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Albuterol (Pf/Sulfuric Acid/Dye Free)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Drug: Albuterol
- Recalling firm
- Pharmacy Innovations
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0192-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Albuterol recalls
See all
Class III · Low risk
Albuterol Sulfate
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Class II · Moderate risk
Airsupra (albuterol and budesonide)
Defective delivery system
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class I · High risk
Albuterol Sulfate Inhalation Aerosol
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Other recalls by Pharmacy Innovations
All 2022 recalls
Class II · Moderate risk
Voriconazole 10mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Vitamin D3-Aqueous- 10
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Vancomycin Fortified 10mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Tobramycin Fortified 15mg/Ml Oph Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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