Drug recall
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC…
FDA recall event 86904 · Class II · Morton Grove Pharmaceuticals, Inc.
Key facts
| Event ID | 86904 |
|---|---|
| Recall numbers | D-0174-2021 |
| Recalling firm | Morton Grove Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities. |
| Initiation date | Dec 9, 2020 |
| Report date | Dec 30, 2020 |
| Termination date | Sep 24, 2022 |
| City | Morton Grove |
| State | IL |
| Country | United States |
| FEI number | 1420913 |
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: