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Recall Observatory FDA recall evidence

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

November 11, 2020

Class III

Product summary

Firm
InvaTech Pharma Solutions, LLC
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

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications