Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Compare with the code on your package — it is the most precise check available.
Drug: Hydrocortisone
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
Subpotent Drug
Subpotent Drug
CGMP Deviations
Failed Stability Specifications
Subpotent Drug
Subpotent Drug
Superpotent Drug: Salicylic acid content is above the firm's specification.
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