Reported Dec 9, 2020 · Terminated
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc.…
InvaTech Pharma Solutions, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: InvaTech Pharma Solutions, LLC · 40c Cotters Ln Ste A · East Brunswick, NJ · 08816-2037
Is this the product you have?
- Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only
- Distributed byMarlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
- Lot codes and dates
Lot #: 051944A Exp. Date April - 20211119124 Exp Date Oct - 2021062088 Exp Date June - 2022
- Amount recalled
- N/A
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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