Pharmacy Innovations recalls injectable estradiol and testosterone products nationwide for sterility assurance
Pharmacy Innovations recalls multiple injectable estradiol and testosterone products due to insanitary facility conditions that compromise sterility assurance. The products were distributed nationwide.
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 with a real hazard to patient safety (lack of sterility assurance due to facility conditions), but no reported illnesses or injuries. This represents a risk-of-harm situation where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Pharmacy Innovations is recalling multiple injectable estradiol and testosterone products distributed nationwide due to insanitary conditions identified during an FDA inspection of the manufacturing facility.
The recalled formulations include estradiol cypionate and testosterone cypionate injectables in various strengths and vial sizes. The insanitary conditions create a lack of assurance of product sterility, which is critical for injectable medications intended for human use.
Patients currently using these products should contact their healthcare provider or pharmacist immediately. Providers may need to assess the need for alternative therapy or replacement products. Specific lot information is available through the FDA and the manufacturer.
The recalled product
- Product
- ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML VI
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- 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)
- t20221109@7 t20221027@6 t20221010@8 t20221116@36 t20221111@45 t20221026@41
Distribution
Distributed nationwide across the United States.
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