Testosterone Cypionate Injectable Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling Testosterone Cypionate (Sesame Oil/Cmpd), 200mg/mL, injectable, 5 mL glass vials. The recall involves 85 mL of product with Lot # 20140714@51 and a discard date of 1/10/2015. The product was distributed in Oregon and Washington.
The recall was initiated due to a lack of sterility assurance. This was identified during a recent FDA inspection, which observed quality control procedures that present a potential risk to sterility assurance for all lots of sterile products compounded by the pharmacy that are not expired.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
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)
- Lot #: 20140714@51
- discard date: 1/10/2015
Distribution
Part of a larger recall action
This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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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