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FDADecember 7, 2016drug

Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654

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

The hazard

Subpotent Drug: Out of specification result for pramoxine hydrochloride

What to do

FDA enforcement status: Terminated

Brands named

novum pharmanovum

Recall history

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

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