Drug recall
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co…
FDA recall event 82375 · Class II · Akorn Inc
Key facts
| Event ID | 82375 |
|---|---|
| Recall numbers | D-1011-2019 |
| Recalling firm | Akorn Inc |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature. |
| Initiation date | Mar 12, 2019 |
| Report date | Mar 27, 2019 |
| Termination date | Aug 1, 2022 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 2315325 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: