Testosterone Cypionate Injectable Vials Recalled Due to Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls Testosterone Cypionate injectable vials distributed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.
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 for an injectable pharmaceutical product where sterility assurance is unavailable. Although no illnesses or injuries have been reported, lack of sterility assurance in an injectable product represents a risk of harm to patients, qualifying it as a high-severity, risk-of-harm recall without reported injury.
Plain-English summary
Olympia Compounding Pharmacy has recalled Testosterone Cypionate 200 mg/mL in grapeseed oil, supplied in multi-dose 10 mL vials. Approximately 2,198 vials are affected (NDC 73198-0054-10). The specific lots recalled are J48011, J42011 (beyond-use date 10/11/2022), and J24C12 (beyond-use date 10/12/2022).
The recall was issued due to lack of assurance of sterility.
The product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands. Patients who have received these vials should contact their prescribing healthcare provider immediately.
The recalled product
- Product
- Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0054-10
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- lack-of-sterility
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 (3)
- Lots: J48011
- J42011 BUD: 10/11/2022
- J24C12 BUD: 10/12/2022
Distribution
Distributed nationwide across the United States.
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