Buprenorphine Injectable Recalled Due to Sterility Assurance Concerns
Pharmacy Innovations is recalling Buprenorphine HCL 0.9 MG/ML injectable vials nationwide due to potential sterility issues discovered during FDA facility inspection. No illnesses have been reported.
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: This is an FDA Class II recall of an injectable drug with a potential sterility/contamination hazard. No illnesses or hospitalizations have been reported, and the hazard is based on facility conditions rather than confirmed contamination. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pharmacy Innovations is recalling Buprenorphine HCL 0.9 MG/ML (25 mL vial) injectable medication manufactured at its Erie, Pennsylvania facility. The recall affects product code t20221118@33 and was distributed nationwide.
The recall was initiated after FDA inspection revealed insanitary conditions at the manufacturing facility that create a lack of assurance of sterility in the affected vials. Injectable medications must maintain strict sterility standards, and the facility conditions discovered during inspection raised concerns about whether those standards were met during production of this product.
Healthcare providers and pharmacies that have received this product should discontinue dispensing it immediately. Patients currently using this medication should contact their healthcare provider or pharmacist for guidance on obtaining an alternative supply. No illnesses or adverse effects related to this recall have been reported to the FDA.
The recalled product
- Product
- Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable / Opioid
- Hazard
- contamination
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)
- t20221118@33
Distribution
Distributed nationwide across the United States.
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