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.

FDA recall notice · announced October 31, 2018 · Lannett

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: 1097, Exp 10/18
Quantity: 8,324 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.