Assurance Infusion Recalls Testosterone Cypionate Oil Due to Sterility Concerns
Assurance Infusion is recalling specific lots of Testosterone Cypionate 200mg/mL oil due to a lack of sterility assurance. The affected vials were distributed nationwide.
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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance in an injectable drug corresponds to a 'Severe' severity score.
Plain-English summary
Assurance Infusion is recalling 5 vials of Testosterone Cypionate 200mg/mL oil in 10 mL vials. The recall is being conducted due to a lack of sterility assurance in the product.
The affected lots include 10242019@7 (exp. 04/21/2020), 10032019@11 (exp. 03/31/2020), 11042019@12 (exp. 05/02/2020), and 09242019@9 (exp. 03/22/2020). These products were distributed nationwide within the United States.
Consumers and healthcare providers should stop using the recalled product and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 5
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 (4)
- Lot: 10242019@7 Exp. 04/21/2020
- 10032019@11 Exp. 03/31/2020
- 11042019@12 Exp. 05/02/2020
- 09242019@9 Exp. 03/22/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Assurance Infusion 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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