FDAFDA · Food and drugs·Recall number D-1011-2019
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
Published March 27, 2019 · Recall initiated: March 12, 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
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn Inc
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Lot: 357647, EXP 04/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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