Drug recall
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex…
FDA recall event 86708 · Class III · InvaTech Pharma Solutions, LLC
Key facts
| Event ID | 86708 |
|---|---|
| Recall numbers | D-0115-2021 |
| Recalling firm | InvaTech Pharma Solutions, LLC |
| Product type | Drugs |
| Products | Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing. |
| Initiation date | Nov 11, 2020 |
| Report date | Dec 9, 2020 |
| Termination date | Jun 20, 2023 |
| City | East Brunswick |
| State | NJ |
| Country | United States |
| FEI number | 3009964119 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: