Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
Reported: December 9, 2020 Initiated: November 11, 2020 #D-0115-2021
Product Description
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
Reason for Recall
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Details
- Recalling Firm
- InvaTech Pharma Solutions, LLC
- Units Affected
- N/A
- Distribution
- Distributed Nationwide in the USA
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product 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. Recalled by InvaTech Pharma Solutions, LLC. Units affected: N/A.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2020. Severity: Low. Recall number: D-0115-2021.
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