The Recall Desk
LowFDA (Drugs)·D-0026-2016·Announced 2015-10-21

Fred's Loratadine Tablets Recalled for Out-of-Specification Assay Results

Ohm Laboratories is recalling Fred's Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result. The FDA classifies this as a Class III recall.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classifies this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Ohm Laboratories, Inc. is recalling Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box. The product is distributed by fred's, Inc. The recall involves 12,960 boxes that were distributed nationwide.

The recall was initiated because the product yielded an out-of-specification (OOS) result for Assay, which is classified as a superpotent drug issue. The affected batch numbers are 2544486, 2544487 (Exp 7/31/2016), 2600127 (Exp 2/29/2016), and 2658140 (Exp 11/30/2016).

The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers should check their medication for the specific batch numbers and expiration dates listed above and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
12,960

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 (7)

  • Batch Numbers: 2544486
  • 2544487
  • Exp 7/31/2016
  • 2600127
  • Exp 2/29/2016
  • 2658140
  • 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 →

Related recalls

Same manufacturer · Ohm Laboratories, Inc.

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