GHK-Cu Injectable Medication Recalled Due to Sterility Assurance Failure
GenoGenix is recalling all lots of GHK-Cu (Copper Peptide) for Injection nationwide due to lack of assurance of sterility. The 221 units affected were distributed across the US.
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: This FDA Class II recall involves a sterility assurance failure for an injectable medication, which qualifies as a risk-of-harm product. The source reports no illnesses, injuries, or deaths, so per the rubric for risk-of-harm products without reported injury, the score is 3.
Plain-English summary
The FDA has announced a Class II recall of GHK-Cu (Copper Peptide) for Injection, manufactured by GenoGenix LLC in Boca Raton, Florida. The recall affects all strengths and presentations of the product, with 221 units distributed nationwide. The reason for the recall is lack of assurance of sterility.
GHK-Cu is an injectable copper peptide medication. Injectable products must be sterile to prevent serious infections and other complications. The absence of assured sterility in this product represents a potential health risk.
All lots of the product remain within their expiration dates at the time of the recall. Consumers who have obtained this product should contact their healthcare provider or the manufacturer for guidance regarding the recall.
The recalled product
- Product
- GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable Medication
- 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)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
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