FDA-Drug2020-12-09Class III

Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30

InvaTech Pharma Solutions, LLC
Hazard

Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

Sold states
Distributed Nationwide in the USA
Affected count
N/A
Manufactured in
40c Cotters Ln Ste A, N/A, East Brunswick, NJ, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0115-2021

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