Class II
Terminated
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.
- Company
- Lannett Company, Inc.
- Recall Initiated
- October 11, 2018
- Posted
- October 31, 2018
- Recall Number
- D-0083-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,324 bottles
- Firm Location
- Philadelphia, PA, United States
Reason for Recall
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 1097, Exp 10/18
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