Loratadine And Pseudoephedrine Sulfate Tablet, Film Coated, Extended Release
FDA Recall NDC 49348-543
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 49348-543). A significant event, classified as Class II, was initiated on Feb 07, 2014 by Strategic Sourcing Services. The reported reason for this action was: "Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg."
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 II Terminated
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Feb 07, 2014
Apr 30, 2014
29,790 blister packs
Recall Profile & Regulatory Data
Event ID
67631
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ohm Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
CA OH, PA, RI,& TX
Termination Date
May 01, 2015
Product Description
Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631 B) Discount Drug Mart Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Loratadine, USP 10 mg/Antihistamine Pseudephrine Sulfate, USP 240 mg/Nasal Decongestant Extended Release Tablets, 15-count box Distributed by Drug Mart-Food Fair Medina, Ohio 44256 UPC 093351116285 C) Kroger Non-Drowsy Allergy and Congestion Loratadine and Pseudoephedrine Extended Release Tablets Pseudoephedrine Sulfate, USP 240 mg Nasal Decongestant Loratadine, USP 10 mg, Antihistamine 10- count box, Distributed by The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-0724-69. D) Sunmark Allergy & Congestion Lorata*dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, Indoor & Outdoor Allergies, Non-Drowsy 10- count box, Distributed by Mckesson One Post Street, San Francisco, CA 94104 NDC 49348-543-01 E) Good Neighbor Pharmacy Non-Drowsy Allergy and Congestion Relief pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine Indoor & Outdoor Allergies Extended-Release Tablets, 10- count box, Distributed by Amerisource Bergen 1300 Morris Drive, Chesterbrook, PA 19087 NDC46122-0167-52 F) H-E-B Allergy Relief - D Non-Drowsy- 24 Hour Formula Loratadine, USP 10mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decogestant Indoor & Outdoor Allegies, Allergy & Congestion Extended-Release Tablets 10-count box, Distributed by H-E-B San Antonio, TX 78204 NDC 37808-0724-69 G) Rite Aid Pharmacy allergy relief & nasal decongestant loratadine USP, 10 mg, pseudoephedribe sulfate USP, 240 mg, antihistamine & nasal degestant, extended release tablets, 10- count box, Distributed by: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 UPC 0118223315555
Batch or Lot Expiration Information
Lot# 2554936, 2554938; Exp 09/15
Affected Packages Involved in this Recall
49348-543-01Product
49348-543-57Product
0504280496Product
0933511162Product
30142-0724-69Product
46122-0167-52Product
37808-0724-69Product
0118223315Product
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.
