Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Hydrocortisone and Acetic Acid Otic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
What was recalled
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
- Recalling firm
- Akorn Inc
- NDC code
- 50383-901-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0839-2020
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.
Other Hydrocortisone recalls
See all
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk Terminated
Essential Calming Skin Gel
Reason Subpotent Drug
Class III · Low risk Terminated
Skin Rehab
Reason Subpotent Drug
Class III · Low risk Terminated
Remedy Gel
Reason Subpotent Drug
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