Drug & medication recalls

InvaTech Pharma Solutions, LLC recalls Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc.…

Recall date
November 11, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0115-2021
FDA classification
Class III
Brand / firm
InvaTech Pharma Solutions, LLC
Sold / distributed
Distributed Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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