Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.