The Recall Desk
ModerateFDA (Drugs)·D-0039-2016·Announced 2015-10-21

Meijer Loratadine Tablets Recalled for Out-of-Specification Assay

Ohm Laboratories is recalling Meijer Loratadine Orally Disintegrating 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 is defined as unlikely to cause adverse health consequences. The hazard is a quality control issue (superpotent drug) without reported injuries or illnesses.

Plain-English summary

Ohm Laboratories, Inc. is recalling 5,040 boxes of Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg. The product is distributed by Meijer Distribution Inc. and is identified by NDC 41250-527-31 and UPC 7 6023662291 8. The specific batch number is 2610783, with an expiration date of 4/30/2016.

The recall was initiated because the product failed to meet specifications for assay, resulting in a superpotent drug classification. This indicates that the amount of active ingredient in the tablets may be higher than intended. The affected units were distributed nationwide.

Consumers who have this product should stop using it and return it to the pharmacy or store where it was purchased. No specific instructions for disposal or refund are provided in the source text.

The recalled product

Product
Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
5,040

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 (2)

  • Batch Number: 2610783
  • Exp 4/30/2016

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 →

Related recalls

Same manufacturer · Ohm Laboratories, Inc.

See all →

Same hazard · superpotent drug

See all →