The Recall Desk
LowFDA (Drugs)·D-0031-2016·Announced 2015-10-21

Major Loratadine Tablets Recalled for Out-of-Specification Assay Results

Ohm Laboratories is recalling Major loratadine orally disintegrating tablets due to out-of-specification assay results. The recall covers 29,360 boxes distributed nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Ohm Laboratories, Inc. is recalling Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box. The recall was initiated because the product failed to meet specifications for assay, a test that measures the amount of active ingredient in the drug. This is classified as a Class III recall by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The affected product is distributed by Major Pharmaceuticals. The recall includes 29,360 boxes of the medication. The specific batch numbers and expiration dates involved are 2644265 (Exp 9/30/2016), 2658140 (Exp 11/30/2016), 2625092 and 2617891 (Exp 5/31/2016), 2600127 (Exp 2/29/2016), and 2544488 and 2544486 (Exp 7/31/2016). The product was distributed nationwide.

Consumers who have this product should check their medication for the NDC 0904-5806-15 or UPC 3 0904580615 9 and the batch numbers listed above. If they have the affected product, they should stop using it and contact their pharmacist or physician for guidance on alternative treatment options.

The recalled product

Product
Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
29,360

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Batch Numbers: 2644265
  • Exp 9/30/2016
  • 2658140
  • Exp 11/30/2016
  • 2625092
  • 2617891
  • Exp 5/31/2016
  • 2600127
  • Exp 2/29/2016
  • 2544488
  • 2544486
  • Exp 7/31/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Ohm Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Related recalls

Same manufacturer · Ohm Laboratories, Inc.

See all →

Same hazard · out of specification

See all →