Reported Oct 31, 2018 · Terminated
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by…
Lannett Company, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lannett Company, Inc. · 9000 State Rd · Philadelphia, PA · 19136-1615
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: 1097Exp 10/18
- Amount recalled
- 8,324 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
This product could cause temporary or reversible health problems — stop using it.
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