Good Sense Aller Ease Tablet, Film Coated
FDA Recall NDC 0113-0847
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 Good Sense Aller Ease (NDC 0113-0847). A significant event, classified as Class II, was initiated on Feb 09, 2023 by L. Perrigo Company. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
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
February 2023 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications
Feb 09, 2023
Jul 19, 2023
32,376 cartons
Recall Profile & Regulatory Data
Event ID
91672
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
L. Perrigo Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
Termination Date
Sep 11, 2023
Product Description
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.
Batch or Lot Expiration Information
Lot# : a) 2DV1869, 2EV1613, 2EV1614, Exp. date 12/23; 2EV1820, 2FV1943, Exp. date 01/24; 2GV1893, Exp. date 04/24.
Lot# : b) 2CR0653, 2DR0466, Exp. date 12/23, 2ER2087, Exp. date 01/24
Affected Packages Involved in this Recall
0113-0847-39Product
0113-0847-95Product
0113-0847-22Product
0113-0847-00Product
0113-0847-47Product
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.
