The Recall Desk
ModerateFDA (Drugs)·D-0032-2016·Announced 2015-10-21

Ohm Allergy Relief Loratadine Recalled for Out-of-Specification Assay

Ohm Laboratories is recalling 311 boxes of Allergy Relief (Loratadine) tablets due to an out-of-specification assay result.

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 indicates a low risk of adverse health consequences. The issue is a quality control failure (out-of-specification assay) rather than a direct safety hazard like contamination or mislabeling of a common allergen.

Plain-English summary

Ohm Laboratories, Inc. is recalling 311 boxes of Allergy Relief (Loratadine) Orally Disintegrating Tablets, USP, 10 mg, 30-count. The recall was initiated because the product produced an out-of-specification (OOS) result for its assay, meaning the drug content did not meet the required standards.

The affected product is distributed nationwide. The specific batch numbers involved are 2544486 (Exp 7/31/2016), 2617891 (Exp 5/31/2016), and 2644272 (Exp 9/30/2016). The product is identified by NDC 51660-527-31 and UPC 3 5166052731 5.

Consumers who have purchased this product should check their lot numbers and expiration dates against the list above. If the product matches the recalled batches, consumers should stop using it and contact Ohm Laboratories for further instructions.

The recalled product

Product
ALLERGY RELIEF (LORATADINE)
Brand
ALLERGY RELIEF
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — OTC Antihistamine
Hazard
Affected units
311

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 (6)

  • Batch Numbers: 2544486
  • Exp 7/31/2016
  • 2617891
  • Exp 5/31/2016
  • 2644272
  • Exp 9/30/2016

UPCs (1)

  • 351660527315

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 brand · ALLERGY RELIEF

Same manufacturer · Ohm Laboratories, Inc.

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Same hazard · out of specification assay

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