Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: AC14635, Exp. Date 12/2022
  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:
SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall:
Failed Moisture Limits
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15

Product Codes/Lot Numbers:

Lot #: AC14635, Exp. Date 12/2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0068-2022

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