FDA (Drugs) recall action 96639
The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.
cGMP deviations
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.
Pharmadel, LLC is recalling Kingskin salicylic acid wart-removal solution due to cGMP manufacturing deviations. The recall affects 20,048 bottles distributed in Delaware.
Pharmadel, LLC is recalling DoloDent Maximum Strength Toothache Drops due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall affects 9,504 bottles distributed in Delaware.
Pharmadel, LLC is recalling Urodel homeopathic chewable tablets for urinary tract infection symptom relief due to cGMP manufacturing deviations. The voluntary recall affects 10,752 bottles distributed in Delaware.
Pharmadel, LLC is recalling Rapidol Arnica Gel (2 oz, 57 g) distributed in Delaware due to manufacturing process deviations. The voluntary recall affects 6,048 bottles of lot EAG-01 with expiration date MAR 27.
Pharmadel, LLC is recalling DoloEar Homeopathic Earache Drops (0.50 oz, 15 mL) due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 27,648 bottles distributed in Delaware.
Pharmadel is recalling 6,048 bottles of Rapidol Arnica Tablets homeopathic medicine due to current good manufacturing practice (cGMP) deviations. The recall affects bottles with lot EAT-01, expiration date March 27, distributed in Delaware.