CLASS II Drug recall · Reported 30 Apr 2014 · FDA Enforcement Report
Non-Drowsy 24 Hour Formula Allergy Relief recalled by Ohm Laboratories
Ohm Laboratories is recalling Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, distributed in California, Pennsylvania, Rhode Island, Texas. The recall was initiated on 7 Feb 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1256-2014
- FDA event ID
- 67631
- Recalling firm
- Ohm Laboratories, North Brunswick, NJ
- Manufacturer
- STRATEGIC SOURCING SERVICES
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2014
- FDA classified
- 23 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Nasal Sprays
Timeline
| 7 Feb 2014 | Recall initiated by company | |
| 23 Apr 2014 | Classified by FDA | +75 days |
| 30 Apr 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
CA OH, PA, RI,& TX
Questions about this recall
Why was it recalled?
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Which lots are affected?
Lot # 2554936, 2554938; Exp 09/15
Where was it sold?
CA OH, PA, RI,& TX
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ohm Laboratories
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|---|---|---|---|---|---|
| Drug | CLASS III | Premier Value Loratadine Orally Disintegrating Tablets recalled | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Equaline Original Prescription Strength recalled by Ohm Laboratories | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Rite Aid Pharmacy loratadine orally disintegrating tablets recalled | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Cvs Pharmacy, Original Prescription Strength recalled | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Up&Up loratadine orally disintegrating tablets recalled | Ohm Laboratories | Potency & Assay | Nationwide |
Other Loratadine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Loratadine-D Extended-Release Tablets (Loratadine recalledLoratadine And Pseudoephedrine Sulfate | SUN Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS III | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate recalledKirkland Signature Allerclear D 24 Hr | SUN Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS II | Children's Loratadine Oral Solution USP, 5 mg recalledChildrens Loratadine | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Ohm Loratadine Orally Disintegrating Tablets recalledAllergy Relief | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Loratadine Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |