Hydroxyzine Hydrochloride Syrup recall: Impurity Out of Spec
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.
Why was Hydroxyzine Hydrochloride Syrup recalled?
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 1097, Exp 10/18
- 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.
- Recalling firm
- Lannett Company, Inc.
- Quantity
- 8,324 bottles
- Distribution
- Nationwide in the USA
- Recall date
- October 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)