Drug product
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
D-0115-2021
Product summary
- Event
- Event 86708
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0115-2021
Official wording
Reason: Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Code information: Lot #: 051944A Exp. Date April - 2021; 1119124 Exp Date Oct - 2021; 062088 Exp Date June - 2022;
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications