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FDADecember 6, 2021drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations

What to do

FDA enforcement status: Terminated

Brands named

edge pharmaedge

UPCs

05446134101

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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