FDA Recalls Testosterone Cypionate Injection Vials for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalled Testosterone Cypionate injection vials due to lack of sterility assurance. The affected lot was distributed nationwide. Patients should contact their healthcare provider immediately.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 drug recall for lack of sterility assurance in an injectable medication. No illnesses or injuries have been reported in the source, but lack of sterility in injectable drugs poses a direct risk of infection, meeting the criterion for High severity.
Plain-English summary
Olympia Compounding Pharmacy has recalled 33 vials of Testosterone Cypionate 200 mg/mL in Sesame Oil due to lack of assurance of sterility. The affected product consists of 5 mL and 10 mL multi-dose vials (NDC 73198-0055-05 and 73198-0055-10). The recalled lot number is J24B13, with a beyond-use date of October 13, 2022.
The product was distributed nationwide throughout the United States, Puerto Rico, and the US Virgin Islands. Testosterone Cypionate is a prescription-only injectable hormone used in hormone replacement therapy and other medical conditions.
Lack of sterility assurance in injectable medications creates a potential risk of infection if contaminated product has been administered. Patients who have received injections from the affected vials should contact their healthcare provider to discuss potential exposure and any symptoms of injection-site infection, such as redness, swelling, or signs of systemic infection.
Patients with prescriptions for this product should contact their pharmacy or healthcare provider. Healthcare providers should also review their patient records to identify any patients who may have received injections from the affected lot.
The recalled product
- Product
- Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.
- Category
- Drug — Injectable Hormone
- Affected units
- 33
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)
- Lot: J24B13 BUD: 10/13/2022
Distribution
Part of a larger recall action
This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy 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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