Testosterone Cypionate Recalled Due to Manufacturing Quality Control Deviations
Olympia Compounding Pharmacy is recalling Testosterone Cypionate 200 mg/mL due to failure to properly investigate manufacturing process monitoring deviations that occurred before October 2021. The recall affects 7,161 vials distributed nationwide.
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 2/5 (Moderate).
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: This is an FDA Class II recall for manufacturing quality control deviations without reported illnesses or documented contamination. Environmental and personnel monitoring excursions were not properly investigated, making this a precautionary recall based on control failures rather than confirmed product defects.
Plain-English summary
Olympia Compounding Pharmacy, dba Olympia Pharmacy, is recalling Testosterone Cypionate 200 mg/mL due to manufacturing quality control deviations. Prior to October 1, 2021, the manufacturer did not properly investigate Out of Action Limit excursions in environmental and personnel monitoring, a violation of current Good Manufacturing Practice (CGMP) requirements. This recall affects 7,161 vials distributed nationwide.
The affected products are 10 mL multi-dose vials (NDC 73198-0054-10) in lots D48027, E47017, F42007, F42107, F42207, F48009, F48109, and H47003, and 5 mL multi-dose vials (NDC 73198-0054-05) in lot F24024. Consumers and healthcare providers should discontinue use of affected vials and contact their pharmacist for guidance on return or replacement. No illnesses have been reported.
The recalled product
- Product
- Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0054-10; b) 5 mL Multi-Dose vial, NDC 73198-0054-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
- Category
- Drug
- Affected units
- 7,161
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 (9)
- Lots: a) D48027 BUD: 4/27/2022
- E47017 BUD: 5/17/2022
- F42007 BUD: 6/7/2022
- F42107 BUD: 6/7/2022
- F42207 BUD: 6/7/2022
- F48009 BUD: 6/9/2022
- F48109 BUD: 6/9/2022
- H47003 BUD: 8/3/2022
- b) F24024 BUD: 6/24/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 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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