The Recall Desk
LowFDA (Drugs)·D-0022-2016·Announced 2015-10-21

Loratadine Tablets Recalled for Out-of-Specification Assay Results

Ohm Laboratories is recalling CareOne Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

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 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 CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg. The recall involves 21,356 boxes of the product, which was distributed nationwide. The specific products affected include 10-count boxes with NDC 41520-525-69 and Children's 10-count boxes with NDC 41520-527-69.

The recall was initiated because the product produced an out-of-specification (OOS) result for Assay, indicating that the drug potency did not meet required standards. This is classified as a superpotent drug issue. Specific batch numbers and expiration dates are listed in the recall documentation.

Consumers who have these products should stop using them and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed
Manufacturer
Ohm Laboratories, Inc.
Category
Drug — Antihistamine
Hazard
Affected units
21,356

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 (11)

  • Batch Numbers: (a) 2617891
  • Exp 5/31/2016
  • 2600127
  • Exp 2/29/2016
  • 2544487
  • Exp 7/31/2015
  • 2610783
  • Exp 4/30/2016 (b) 2600127
  • 2617891
  • 2644272
  • 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 →

Related recalls

Same manufacturer · Ohm Laboratories, Inc.

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Same hazard · potency failure

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