Pharmacy Innovations Testosterone Injectables and Ophthalmic Products Recalled for Sterility Concerns
Pharmacy Innovations is recalling multiple testosterone injectable and ophthalmic formulations nationwide due to insanitary facility conditions that prevent assurance of sterile manufacturing.
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 recall involves injectable and ophthalmic drugs where insanitary manufacturing conditions prevent assurance of sterility. No illnesses or injuries are reported in the source. Per the severity rubric, this qualifies as 'risk-of-harm products where injury has not yet been reported,' corresponding to High (Score 3).
Plain-English summary
Pharmacy Innovations, located in Erie, Pennsylvania, is recalling testosterone formulations distributed nationwide, including injectable testosterone cypionate products at various strengths and ophthalmic ointment, some in combination with anastrozole or estradiol.
The U.S. Food and Drug Administration classified this as a Class II recall after inspecting the facility and discovering insanitary conditions. These conditions prevent assurance that the products were manufactured under sterile conditions, which is essential for the safety of injectable and ophthalmic drugs.
Patients and healthcare providers who have received these recalled products should consult their healthcare provider about potential risks and alternative treatment options.
The recalled product
- Product
- TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/0.5MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP/A
- Manufacturer
- Pharmacy Innovations
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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