Injectable Testosterone Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 520 vials of Ultratest testosterone injectable due to lack of sterility assurance. The recall affects distribution nationwide in the USA, Puerto Rico, and US Virgin Islands.
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 recall for lack of sterility assurance in injectable testosterone product. Although no illnesses or injuries are reported, injectable medications lacking sterility assurance present an inherent risk of serious bacterial infection and meet the criteria for High severity as risk-of-harm products.
Plain-English summary
Olympia Compounding Pharmacy is recalling Ultratest Testosterone Cypionate 160 mg/mL and Testosterone Propionate 40 mg/mL multi-dose vials (10 mL size, NDC 73198-0058-10). Affected lot numbers are J24014 and J24114, with a beyond-use date of 10/14/2022.
The recall is being issued because the FDA determined there is a lack of assurance of sterility for the product.
A total of 520 vials are subject to this recall and were distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands.
Patients who have received this product should contact their healthcare provider to discuss potential risks and appropriate follow-up. Healthcare providers should stop dispensing the affected lots and identify patients who may have received the product.
The recalled product
- Product
- Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0058-10
- Category
- Drug — Compounded Injectable
- Affected units
- 520
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 (2)
- Lots: J24014
- J24114 BUD: 10/14/2022
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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