FDAFDA · Food and drugs·Recall number D-0083-2019
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.
Published October 31, 2018 · Recall initiated: October 11, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HYDROXYZINE HYDROCHLORIDE
- Manufacturer
- Lannett Company, Inc.
- Distributor
- Nationwide in the USA
- UPC
- 0354838502800
- Lot
- Lot #: 1097, Exp 10/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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