Reported Feb 19, 2020 · Terminated
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC.,…
Akorn Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn Inc · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: 364667Exp 12/20/2019
- Amount recalled
- 16,078 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
This product could cause temporary or reversible health problems — stop using it.
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