Dutasteride Injectable Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling Dutasteride 0.1% injectable vials nationwide due to FDA-identified insanitary facility conditions that compromised sterility assurance. Patients should consult their healthcare provider about this prescription medication.
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 recall for lack of sterility assurance in a sterile injectable product due to facility contamination. While no illnesses, injuries, or hospitalizations are reported in the source, this represents a significant risk-of-harm scenario (potential infection from compromised sterility) where injury has not yet been reported, meeting the Score 3 criterion.
Plain-English summary
Pharmacy Innovations is recalling Dutasteride 0.1% (1.5 mL vial) injectable medication due to lack of assurance of sterility. An FDA inspection of the manufacturing facility located at 2936 W 17th St., Erie, PA, revealed insanitary conditions that could compromise the sterility of the injectable product.
This product was distributed nationwide in the United States. Affected vials are identified by lot codes 20221012@21, t20221025@32, and t20221109@7.
Patients currently using this medication should contact their prescribing healthcare provider or pharmacist immediately to discuss their options. Do not use remaining doses of the recalled product. Healthcare providers and pharmacists should quarantine and cease dispensing this product.
The recalled product
- Product
- Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- facility-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)
- 20221012@21 t20221025@32 t20221109@7
Distribution
Distributed nationwide across the United States.
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