The Recall Desk
LowFDA (Drugs)·D-0023-2016·Announced 2015-10-21

CVS Loratadine Tablets Recalled for Out-of-Specification Assay Results

CVS Pharmacy loratadine tablets are being recalled because they failed potency testing. Consumers should stop using the product and return it to the pharmacy.

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 classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The hazard is a potency failure rather than a toxic contamination or physical defect.

Plain-English summary

CVS Pharmacy, Inc. is recalling CVS Pharmacy, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg. The recall involves 10-count and 30-count boxes distributed nationwide by CVS Pharmacy, Inc. The product was manufactured by Ohm Laboratories, Inc.

The recall was initiated because the product failed an out-of-specification (OOS) test for assay, which measures the potency of the drug. This means the tablets may not contain the correct amount of the active ingredient.

Consumers who have purchased these specific tablets should stop using them and return them to their pharmacy for a refund or replacement. The recall covers specific batch numbers and expiration dates listed in the official FDA notice.

The recalled product

Product
CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. On
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
291,312

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 (20)

  • Batch Numbers: a) 2644273
  • 2644265
  • Exp 9/30/2016
  • 2617891
  • 2617892
  • 2617893
  • Exp 5/31/2016
  • 2625093
  • 6/30/2016
  • 2544488
  • 7/31/2016
  • 2600125
  • 2600126
  • 2600127
  • Exp 2/29/2016
  • 2610783
  • Exp 4/30/2016 b) 2600128
  • 2544487
  • Exp 7/31/2016
  • 2644272

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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Same hazard · potency failure

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