Drug recall D-0083-2019
Product
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.
Reason for recall
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Lots and codes
Lot #: 1097, Exp 10/18
Recall details
- Recalling firm
- Lannett Company, Inc., Philadelphia, PA
- Quantity
- 8,324 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 11, 2018
- Terminated
- February 22, 2019
Related products
- Hydroxyzine Hydrochloride – drug information
- NDC 54838-502 Hydroxyzine Hydrochloride · Hydroxyzine Dihydrochloride 10 mg/5mL · Lannett Company, Inc.