Class II · Moderate risk
Med Pride
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.
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.
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.
Affected NDC
50383-0901-10
Compare with the code on your package — it is the most precise check available.
Drug: Hydrocortisone
- Recalling firm
- Akorn Inc
- NDC code
- 50383-901-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0839-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydrocortisone recalls
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Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk
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Class III · Low risk
Skin Rehab
Subpotent Drug
Class III · Low risk
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Other recalls by Akorn Inc
All 2019 recalls
Class II · Moderate risk
Tropicamide Ophthalmic Solution
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Class II · Moderate risk
Ropivacaine Hydrochloride Injection USP
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Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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