Ultratest testosterone injection recalled for manufacturing monitoring deviations
Olympia Compounding Pharmacy recalled 1,276 vials of Ultratest testosterone injection nationwide. Prior to October 2021, the manufacturer failed to properly investigate environmental and personnel monitoring deviations per FDA manufacturing standards.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is manufacturing process-related (failure to properly investigate environmental monitoring excursions), and the recall is precautionary in nature, fitting the criteria for Moderate severity.
Plain-English summary
Ultratest is a compounded testosterone injection manufactured by Olympia Compounding Pharmacy. The product contains testosterone cypionate 160 mg/mL and testosterone propionate 40 mg/mL in 10 mL multi-dose vials. The affected lots are E48020 (beyond-use date May 20, 2022) and G47006 (beyond-use date July 6, 2022), totaling 1,276 vials.
The recall was initiated because prior to October 1, 2021, environmental and personnel monitoring out-of-action-limit (OOAL) excursions were not being properly investigated in accordance with Current Good Manufacturing Practice (CGMP) requirements. This monitoring process is critical for ensuring the sterility and safety of compounded injectables.
The product was distributed nationwide throughout the United States.
The recalled product
- Product
- Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- manufacturing-deviation
- sterile-compounding-violation
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)
- Lots: E48020 BUD: 5/20/2022 and G47006 BUD: 7/6/2022
Distribution
Distributed nationwide across the United States.
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