Injection Products Recalled for Lack of Sterility Assurance by GenoGenix
BPC-157/Thymosin Beta-4 injections from GenoGenix are being recalled due to lack of assurance of sterility. The recall affects products distributed nationwide.
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 recall with no reported illnesses or injuries. The hazard—lack of sterility assurance in injectable products—represents a preventive measure to prevent potential infection and contamination rather than a confirmed safety event. Per the rubric, high-risk products where injury has not yet been reported score 3 (High).
Plain-English summary
BPC-157/Thymosin Beta-4 for Injection is being recalled by GenoGenix LLC and products labeled for CELIA Health, Extension Health, and Medical Health Institute (MHI). The recall affects all presentations (10/10mg, 15/15mg, and 15mg/15mg). Affected lot numbers are GG020525-001, GG060525-001, and GG062625-004, which remain within their expiration dates.
The product is being recalled because the manufacturer cannot assure sterility of the injectable products. Sterile injectable medications must be manufactured under strict conditions to prevent contamination and potential harm to patients.
These products have been distributed nationwide. Patients, healthcare providers, and distributors who have received these products should contact GenoGenix LLC or their healthcare provider for guidance.
The recalled product
- Product
- BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injection / Injectable
- Hazard
- lack-of-sterility
- injectable-contamination
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#: GG020525-001
- GG060525-001
- GG062625-004
- within expiry.
Distribution
Distributed nationwide across the United States.
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