GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72

Class I - Dangerous
💊 Drugs Recalled: June 7, 2022 Plastikon Healthcare Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # 20091A, EXP Sep. 2022; 20104A, EXP Nov. 2022; 21017A, EXP Feb. 2023; 21034A, 21036A EXP Mar. 2023; 21092A, EXP Aug. 2023; 21105A, 21106A, EXP Oct. 2023; 21134A, EXP Dec. 2023; 22007B, EXP Jan. 2024; 22012A, EXP Feb. 2024; 22016B, EXP Mar. 2024
  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:
Plastikon Healthcare LLC
Reason for Recall:
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72

Product Codes/Lot Numbers:

Lot # 20091A, EXP Sep. 2022; 20104A, EXP Nov. 2022; 21017A, EXP Feb. 2023; 21034A, 21036A EXP Mar. 2023; 21092A, EXP Aug. 2023; 21105A, 21106A, EXP Oct. 2023; 21134A, EXP Dec. 2023; 22007B, EXP Jan. 2024; 22012A, EXP Feb. 2024; 22016B, EXP Mar. 2024

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1491-2022

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