The Recall Desk
ModerateFDA (Drugs)·D-0036-2016·Announced 2015-10-21

Ohm Recalls Up&Up Loratadine Tablets for Out-of-Specification Assay

Ohm Laboratories is recalling Up&Up loratadine tablets because they failed an assay test, potentially making them superpotent.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a potential superpotent dose due to an assay failure, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Ohm Laboratories, Inc. is recalling Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count boxes. The recall was initiated because the product produced an out-of-specification (OOS) result for assay, which indicates the tablets may be superpotent.

The affected product is distributed by Target Corp in Minneapolis, MN, and was distributed nationwide. The recall involves 34,488 boxes with specific batch numbers and expiration dates ranging from May 31, 2016, to November 30, 2016. The NDC is 11673-527-31 and the UPC is 3 5166052731 5.

Consumers should check their medication for the listed batch numbers and expiration dates. If they have the affected product, they should stop using it and contact their pharmacist or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Oral Solid Dosage
Hazard
Affected units
34,488

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 (9)

  • Batch Numbers: 2617892
  • 2617893
  • Exp 5/31/2016
  • 2625092
  • 2625093
  • Exp 6/30/2016
  • 2658137
  • 2658138
  • Exp 11/30/2016

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 →

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