Loratadine And Pseudoephedrine Sulfate Tablet, Film Coated, Extended Release
FDA Recall NDC 0904-5833
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 Loratadine And Pseudoephedrine Sulfate (NDC 0904-5833). A significant event, classified as Class III, was initiated on Oct 12, 2021 by Major Pharmaceuticals. 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
22,752 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
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
Batch or Lot Expiration Information
Lot# : AC14635, Exp. Date 12/2022
Affected Packages Involved in this Recall
0904-5833-15Product
0904-5833-48Product
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.
