Kirkland Signature Allerclear D 24 Hr Tablet, Extended Release
FDA Recall NDC 63981-724
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 Kirkland Signature Allerclear D 24 Hr (NDC 63981-724). A significant event, classified as Class III, was initiated on Oct 12, 2021 by Kirkland-costco Wholesale Company. The reported reason for this action was: "Failed Moisture Limits"
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
Failed Moisture Limits
Oct 12, 2021
Nov 03, 2021
46,584 blister packs
Recall Profile & Regulatory Data
Event ID
88806
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Aug 31, 2023
Product Description
AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15
Batch or Lot Expiration Information
Lot# AC09723, Exo, Date 11/2022
Affected Packages Involved in this Recall
63981-724-15Product
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.
