Drug 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.
D-0083-2019
Product summary
- Event
- Event 81225
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,324 bottles
- Official record key
drug-enforcement:D-0083-2019
Official wording
Reason: CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Code information: Lot #: 1097, Exp 10/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
out of specification