Recalls / Class II
Class IID-0434-2022
Product
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03
- Affected lot / code info
- 09-2021-15@5 12-14-2021 & 10-2021-01@4 12-30-2021
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Edge Pharma, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 856 Hercules Dr, Colchester, Vermont 05446-8014
Distribution
- Quantity
- 63 vials
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2021-12-06
- FDA classified
- 2022-01-24
- Posted by FDA
- 2022-02-02
- Terminated
- 2023-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0434-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.