InvaTech Recalls Levocetirizine Dihydrochloride Tablets Due to Stability Failure
InvaTech Pharma Solutions is recalling specific lots of Levocetirizine Dihydrochloride Tablets 5 mg because one lot failed stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a stability testing failure without reported injuries.
Plain-English summary
InvaTech Pharma Solutions, LLC is recalling specific lots of Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottles. The product is distributed by Marlex Pharmaceuticals, Inc. and is available nationwide in the USA.
The recall was initiated because one lot of the tablets failed stability testing, resulting in failed impurities or degradation specifications. The affected lots include Lot #051944A (Exp. April 2021), Lot #1119124 (Exp. October 2021), and Lot #062088 (Exp. June 2022).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for disposal or replacement.
The recalled product
- 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
- Manufacturer
- InvaTech Pharma Solutions, LLC
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 051944A Exp. Date April - 2021
- 1119124 Exp Date Oct - 2021
- 062088 Exp Date June - 2022
Distribution
Distributed nationwide across the United States.
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