Injectable Ethyl Alcohol 95% Recalled Due to Sterility Assurance Concerns
Pharmacy Innovations is recalling Ethyl Alcohol 95% (5ML vial) Injectable nationwide because FDA inspection revealed insanitary conditions at the manufacturing facility that compromise sterility assurance.
What this means for you
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: FDA Class II classification applies, but no illnesses, injuries, or deaths are documented in the source. The hazard—insanitary facility conditions—presents a theoretical risk to product sterility rather than confirmed contamination, placing this in the High category for risk-of-harm products without reported injury.
Plain-English summary
Pharmacy Innovations is recalling Ethyl Alcohol 95% (5ML vial) Injectable, a prescription pharmaceutical, nationwide. The recall was initiated after an FDA inspection revealed insanitary conditions at the manufacturing facility.
Because the facility did not maintain sanitary conditions, the FDA determined there is no assurance that the product meets sterility requirements necessary for injectable pharmaceutical use.
This recall affects distribution nationwide in the USA. Consumers and healthcare facilities in possession of this product should discontinue use and contact Pharmacy Innovations regarding proper disposition of recalled inventory.
The recalled product
- Product
- Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable Pharmaceutical
- Hazard
- contamination-risk
- manufacturing-defect
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)
- t20221013@15
Distribution
Distributed nationwide across the United States.
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