Drug recall
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx…
FDA recall event 67894 · Class II · Hi-Tech Pharmacal Co., Inc.
Key facts
| Event ID | 67894 |
|---|---|
| Recall numbers | D-0048-2015 |
| Recalling firm | Hi-Tech Pharmacal Co., Inc. |
| Product type | Drugs |
| Products | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station. |
| Initiation date | Apr 1, 2014 |
| Report date | Nov 5, 2014 |
| Termination date | Sep 21, 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: