Thymosin Beta-4 Injectable Recalled for Lack of Sterility Assurance
GenoGenix's Thymosin Beta-4 15mg injectable is recalled due to lack of assurance of sterility. Lot GG060525-001 has been distributed nationwide; patients should consult their healthcare provider.
What this means for you
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: FDA Class II injectable with lack of sterility assurance presents theoretical risk of infection from non-sterile product. Per the severity rubric, recalls without reported illnesses and with theoretical hazards score at most High severity.
Plain-English summary
GenoGenix LLC is recalling all presentations of Thymosin Beta-4 (TB4) for Injection, 15mg due to lack of assurance of sterility. The manufacturer was unable to guarantee that manufacturing controls ensured sterile conditions for this injectable product.
The affected product lot is GG060525-001, which has been distributed nationwide across the United States. Patients and healthcare facilities that received this lot should take immediate action.
Consumers and healthcare providers should discontinue use of this lot immediately. If you or a patient in your care has received an injection from this lot, contact your healthcare provider for guidance. Patients should be monitored for signs of infection or other complications. Report any adverse events to the FDA MedWatch program.
The recalled product
- Product
- Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- infection-risk
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)
- Lot#: GG060525-001 within expiry.
Distribution
Distributed nationwide across the United States.
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