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Regulatoryghk-cuphilippine fdaunregistered productsinjectables

Philippine FDA warns against unregistered injectable GHK-Cu 100 mg product

Post-marketing surveillance found the copper peptide injection and its bacteriostatic water diluent were sold without a Certificate of Product Registration.

DO
By Daniel Okafor · Regulatory Correspondent
Sep 28 22:07 ETSource: fda.gov.ph

The wire

  1. 01The Philippine FDA issued Advisory No. 2026-1278 against GHK-Cu 100 mg lyophilized powder for subcutaneous injection, supplied with bacteriostatic water containing 0.9% benzyl alcohol, after verifying it holds no Certificate of Product Registration.
  2. 02The agency says buyers have no assurance of quality, safety or efficacy, and warns that manufacture, import, sale, distribution or advertising of unauthorized health products is prohibited under Republic Act No. 9711.
  3. 03Local government units and law enforcement were asked to keep the product off shelves; no injuries were reported in the advisory, and no manufacturer was named.

From the source

FDA Advisory No.2026-1278 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product “GHK-CU 100 mg (Glycyl-L-histidyl-L-lysine copper complex) Lyophilized Powder for Injection for Subcutaneous Use Only and Bacteriostati

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

Read at fda.gov.ph
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