Cetirizine Tablet, Film Coated
FDA Recall NDC 50090-5510
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cetirizine (NDC 50090-5510). A significant event, classified as Class III, was initiated on Oct 05, 2021 by A-s Medication Solutions. The reported reason for this action was: "Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Oct 05, 2021
Nov 17, 2021
72 bottles
Recall Profile & Regulatory Data
Event ID
88853
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
A-S Medication Solutions LLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, IN, MN, WI
Termination Date
Aug 12, 2022
Product Description
Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3
Batch or Lot Expiration Information
Lot# : 1256330
Affected Packages Involved in this Recall
50090-5510-1Product
50090-5510-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
