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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67631

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 07, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ohm Laboratories, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-1256-2014
Recall number
D-1256-2014
Initiated
February 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Ohm Laboratories, Inc.
Quantity
29,790 blister packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot # 2554936, 2554938; Exp 09/15

Distribution pattern

CA OH, PA, RI,& TX