Drug 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).
D-0086-2026
Product summary
- Firm
- GenoGenix LLC
- Event
- Event 97369
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0086-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: GG020525-001, GG060525-001, GG062625-004, within expiry.
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility