Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    NDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp. 3/31/19 3083760, Exp. 3/31/19 3083761, Exp. 3/31/19
  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:
Mylan Pharmaceuticals Inc.
Reason for Recall:
CGMP Deviations
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

Product Codes/Lot Numbers:

NDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp. 3/31/19 3083760, Exp. 3/31/19 3083761, Exp. 3/31/19

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0824-2018

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