FDAFDA · Food and drugs·Recall number D-0115-2021
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
Published December 9, 2020 · Recall initiated: November 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- InvaTech Pharma Solutions, LLC
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot #: 051944A Exp. Date April - 2021; 1119124 Exp Date Oct - 2021; 062088 Exp Date June - 2022;
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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