FDAFDA · Food and drugs·Recall number D-0839-2020
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.
Published February 19, 2020 · Recall initiated: December 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn Inc
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot #: 364667, Exp 12/20/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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