Philippine FDA warns against unregistered 30mg tirzepatide multi-use vials
The agency says the product and accompanying bacteriostatic water vials never obtained a Certificate of Product Registration, leaving quality, safety and efficacy unverified.
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By Daniel Okafor · Regulatory Correspondent
Oct 20 09:08 ETSource: https://www.fda.gov.ph/
The wire
- 01The Philippine FDA issued Advisory No. 2026-1020 against "Tirzepatide Subcutaneously Use Only 30MG Multi-Use Vial and Bac Water 0.9% Benzyl Alcohol 3ml Multiple Vial Dose" after post-marketing surveillance found no registration.
- 02Multi-use high-concentration tirzepatide vials sold with bacteriostatic water are a familiar gray-market format, and regulators outside the US are now naming specific presentations.
- 03Distribution is prohibited under Republic Act No. 9711 until authorization is granted; the agency asked local governments and law enforcement to pull the product and is collecting adverse-reaction reports.
From the source
Read at fda.gov.phFDA Advisory No.2026-1020 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product “Tirzepatide Subcutaneously Use Only 30MG Multi-Use Vial and Bac Water 0.9% Benzyl Alcohol 3ml Multiple Vial Dose”
The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug product:
