Albuterol Inhalation Solution Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling nationwide Albuterol 0.083% inhalation solution in 3ML tubes due to insanitary manufacturing facility conditions that compromise sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm product (inhalation medication for respiratory use) where no injuries have been reported. The hazard—lack of sterility assurance due to insanitary facility conditions—poses potential contamination risk, but no confirmed adverse events are documented in the source.
Plain-English summary
Pharmacy Innovations is recalling its Albuterol (Preservative-Free/Sulfuric Acid/Dye Free) 0.083% Inhalation Solution in 3ML tubes nationwide. The affected product carries batch codes t20221011@36 and t20221108@24.
The recall was initiated because an FDA inspection of the manufacturing facility in Erie, Pennsylvania revealed insanitary conditions that compromise the assurance of product sterility.
The recalled product
- Product
- Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- t20221011@36 t20221108@24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by Pharmacy Innovations under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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