Drug recall
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701…
FDA recall event 65017 · Class III · Hi-Tech Pharmacal Co., Inc.
Key facts
| Event ID | 65017 |
|---|---|
| Recall numbers | D-302-2013 |
| Recalling firm | Hi-Tech Pharmacal Co., Inc. |
| Product type | Drugs |
| Products | Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station. |
| Initiation date | Mar 11, 2013 |
| Report date | May 8, 2013 |
| Termination date | May 13, 2016 |
| City | Amityville |
| State | NY |
| Country | United States |
| FEI number | 2433247 |
At a glance
- 1–9 Products in this recall
- 10–99 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: