AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot # 12DQ002, Exp. 03/14.
  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:
TG United, Inc.
Reason for Recall:
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16

Product Codes/Lot Numbers:

Lot # 12DQ002, Exp. 03/14.

Distribution:

Distributed in: FL, MS, SC, LA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-504-2013

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