The Recall Desk
ModerateFDA (Drugs)·D-0019-2016·Announced 2015-10-21

QC Quality Choice Loratadine Tablets Recalled for Out-of-Specification Assay

Ohm Laboratories is recalling QC Quality Choice 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 indicates the product is unlikely to cause adverse health consequences, fitting the Moderate severity criteria for minor labeling or specification errors.

Plain-English summary

Ohm Laboratories, Inc. is recalling QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box. The recall involves 8,735 units distributed nationwide. The specific batch numbers and expiration dates are 2644273 (Exp 9/30/2016), 2600127 (Exp 3/20/2016), and 2544486 (Exp 7/31/2016).

The recall was initiated because the product produced an out-of-specification (OOS) result for Assay, which is classified as a superpotent drug issue. This means the amount of active ingredient in the tablets may not meet the required standards.

Consumers who have these specific tablets should stop using them and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
8,735

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: 2644273
  • Exp 9/30/2016
  • 2600127
  • Exp 3/20/2016
  • 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 →

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Same manufacturer · Ohm Laboratories, Inc.

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Same hazard · out of specification

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