Drug recall
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only…
FDA recall event 81225 · Class II · Lannett Company, Inc.
Key facts
| Event ID | 81225 |
|---|---|
| Recall numbers | D-0083-2019 |
| Recalling firm | Lannett Company, Inc. |
| Product type | Drugs |
| Products | HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. |
| Initiation date | Oct 11, 2018 |
| Report date | Oct 31, 2018 |
| Termination date | Feb 22, 2019 |
| City | Philadelphia |
| State | PA |
| Country | United States |
| FEI number | 2510865 |
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: