Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marl...
FDA Recall #D-0115-2021 — Class III — November 11, 2020
Product Description
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
Reason for Recall
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Recalling Firm
InvaTech Pharma Solutions, LLC — East Brunswick, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Distributed Nationwide in the USA
Code Information
Lot #: 051944A Exp. Date April - 2021; 1119124 Exp Date Oct - 2021; 062088 Exp Date June - 2022;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated