Testosterone Cypionate Vials Recalled Due to Manufacturing Quality Control Deviation
Olympia Compounding Pharmacy recalls Testosterone Cypionate vials nationwide due to deviations in manufacturing quality monitoring procedures prior to October 2021.
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 indicating potential for adverse health consequences, but no illnesses or injuries have been reported. The hazard is a CGMP deviation in manufacturing monitoring procedures; while the potential for harm exists, it remains unconfirmed.
Plain-English summary
Olympia Compounding Pharmacy is recalling Testosterone Cypionate 200 mg/mL (in sesame oil) injection vials distributed nationwide in the United States. Approximately 3962 vials are affected across multiple lot numbers.
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. These monitoring failures represent deviations from Good Manufacturing Practice (CGMP) requirements.
Patients currently using affected medication should consult their healthcare provider regarding their treatment. Those who have affected product should contact their pharmacy or healthcare provider for guidance on returning or properly disposing of the medication.
The recalled product
- Product
- Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0055-10; b) 5 mL Multi-Dose vial, NDC 73198-0055-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
- Category
- Drug — Compounded Injectable
- Affected units
- 3,962
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 (6)
- Lots: a) E48019 BUD: 5/19/2022
- F42109 BUD: 6/9/2022
- F42C09 BUD: 6/9/2022
- G47012 BUD: 7/12/2022
- G47112 BUD: 7/12/2022
- b) F42B09 BUD: 6/9/2022
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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