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U.S. Department of Health and Human Services

Enforcement Report - Week of April 30, 2014

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Product Detail

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
Recall Number D-1256-2014
Classification Class II
Code Info Lot # 2554936, 2554938; Exp 09/15
Product Distributed Qty 29,790 blister packs
Reason For Recall Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

Event Detail

Event Id 67631
Product Type Drugs
Status Ongoing
Recalling Firm Ohm Laboratories, Inc.
City North Brunswick
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern CA OH, PA, RI,& TX
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