Agency classClass IIOur severity:High FDA (Drugs)·D-0911-2022·Announced 2022-06-01

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.

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: 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
Affected units: 2,198

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.

The notice also names 2 states specifically:

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.

See all 53 products in this recall →

Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy

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