🔍 RecallPedia

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 by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086

Class I - Dangerous
💊 Drugs Recalled: July 28, 2015 Ohm Laboratories Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ohm Laboratories, Inc.
Reason for Recall:
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086

Product Codes/Lot Numbers:

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, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0022-2016

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