FDA (Drugs) recall action 99137
The FDA (Drugs) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
CGMP Deviations; deficiencies observed during FDA inspection
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Med Pride Hydrocortisone Cream 1%, 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,944 tubes are affected.
Lucky Super Soft First Aid Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 2,503 tubes are affected.
Lucky Super Soft Antifungal Athlete's Foot Cream, clotrimazole 1%, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,102 tubes affected.
Lil Drug Store Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,225 tubes affected.
Cura Hongos Crema Antifungica, clotrimazole 1%, in 2 oz tubes is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 84 tubes affected.
Med Pride Bacitracin Zinc Ointment, 1 oz tubes, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,185 tubes affected.
Med Pride Triple Antibiotic Ointment in 0.9 g packets is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 3,006 tubes affected.
Med Pride Triple Antibiotic Ointment in 1 oz tubes is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 8,996 tubes are affected.
Rapidol Triple Antibiotic First Aid Ointment, 2 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 84 tubes are affected.
Circle K Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 2,420 tubes are affected.
Med Pride 1% Clotrimazole Antifungal Cream, 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 5,755 tubes are affected.
Med Pride Hydrocortisone Cream 1%, 16 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,738 tubes are affected.
Med Pride Bacitracin Zinc Ointment, 500 units in 0.9 g packets, is being recalled because of CGMP deviations observed during an FDA inspection. 1,087 tubes affected.
Med Pride Bacitracin Zinc Ointment, 500 units per gram in 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,374 tubes affected.