The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0033-2016·Announced 2015-10-21

Ohm Laboratories Recalls Loratadine Tablets for Out-of-Specification Assay

Ohm Laboratories is recalling Premier Value Loratadine Orally Disintegrating Tablets because an assay test result was out of specification.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 hazard is a quality control issue (out-of-specification assay) without reported injuries or illnesses.

Plain-English summary

Ohm Laboratories, Inc. is recalling Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box. The recall is due to an out-of-specification (OOS) result for the assay test, which measures the amount of active ingredient in the drug product.

The affected product is distributed by Chain Drug Consortium. The recall involves 11,232 boxes distributed nationwide. The specific batch numbers are 2600126 (Exp 2/29/2016) and 2644273 (Exp 9/30/2016).

Consumers should check their medication for these specific batch numbers and expiration dates. If the product matches the recalled description, consumers should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
11,232

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 (4)

  • Batch Numbers: 2600126
  • Exp 2/29/2016
  • 2644273
  • Exp 9/30/2016

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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