Berkley Jensen Allergy Relief Tablet, Film Coated
FDA Recall NDC 68391-847
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 Berkley Jensen Allergy Relief (NDC 68391-847). A significant event, classified as Class II, was initiated on Feb 09, 2023 by Bjwc. 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
23,868 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
Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Research Drive, Westborough, MA 01581. NDC 68391-847-47
Batch or Lot Expiration Information
Lot# :2DV1863, 2HV2698, Exp. date 12/23; 2GV1583, Exp. date 02/24; 2GV1950, 2HV2697, Exp. Date 01/24.
Affected Packages Involved in this Recall
68391-847-47Product
68391-847-48Product
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.
