Class II · Moderate risk Terminated
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only…
Reason cGMP deficiencies
Is Pramoxine recalled?
5 FDA recalls mention Pramoxine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pramoxine.
Class II · Moderate risk Terminated
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive…
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115…
Reason cGMP Deviations.
Class III · Low risk Terminated
Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC…
Reason Subpotent Drug: Out of specification result for pramoxine hydrochloride
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