Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.

Class I - Dangerous
💊 Drugs Recalled: June 21, 2019 Pharma-Natural Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots remaining within expiry.
  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:
Pharma-Natural Inc.
Reason for Recall:
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.

Product Codes/Lot Numbers:

All lots remaining within expiry.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1503-2019

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