Class II · Moderate risk
Proctofoam HC
cGMP deficiencies
Most common reason: cGMP deviation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pramoxine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
cGMP deficiencies
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
cGMP Deviations.
cGMP Deviations.
Subpotent Drug: Out of specification result for pramoxine hydrochloride
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