Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Albuterol 3.75mg / Ipratropium 0.75mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Drug: Albuterol
- Recalling firm
- Integrated Health Concepts Inc. dba Conversio Health
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0509-2020 · 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 Integrated Health Concepts Inc. dba Conversio Health
All 2019 recalls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Budesonide 0.5mg
Lack of Processing Controls
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