NDC 54868-4336
Hydroxyzine Hydrochloride 10 mg per 5 mL syrup
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Morton Grove Pharmaceuticals, Inc.'s NDC 60432-150.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Morton Grove Pharmaceuticals, Inc. | Morton Grove, Illinois, United States | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 5, 2016 · 6 inspections, 1 with FDA action |
Recalls
- Dec 9, 2020 · Class II · Morton Grove Pharmaceuticals, Inc.
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Lots: Lot#: a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydroxyzine: every company that makes it
- Form
- syrup
- Strength
- 10 mg per 5 mL
- Approval
- ANDA ANDA087294
- On the market since
- Sep 13, 2000
- Package NDCs
54868-4336-054868-4336-1- Official label
- DailyMed (National Library of Medicine), updated Jan 5, 2010
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