D-0115-2021 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 9, 2020
- Initiation Date
- November 11, 2020
- Termination Date
- June 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot #: 051944A Exp. Date April - 2021; 1119124 Exp Date Oct - 2021; 062088 Exp Date June - 2022;