Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Promethazine HCl Topical Ointment Recalled by Edge Pharma, LLC Due to CGMP Deviations
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edge Pharma, LLC directly.
Affected Products
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
Quantity: 7788 syringes
Why Was This Recalled?
CGMP Deviations
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Edge Pharma, LLC
Edge Pharma, LLC has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report