My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: M16317A1, M16317A4, M16317A5, Exp 11/18
  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:
Lupin Pharmaceuticals Inc.
Reason for Recall:
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.

Product Codes/Lot Numbers:

Lot #: M16317A1, M16317A4, M16317A5, Exp 11/18

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0837-2018

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