The Recall Desk
HighFDA (Drugs)·D-1491-2022·Announced 2022-09-14

Guaifenesin and Dextromethorphan Cough Syrup Recalled for Manufacturing Control Deviations

Plastikon Healthcare LLC is recalling Guaifenesin and Dextromethorphan cough syrup cups distributed nationwide due to manufacturing processes that were not adequately controlled.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for manufacturing control deviations represents a risk-of-harm situation. No illnesses or injuries have been reported, but manufacturing process control failures are considered potential quality and safety risks per the rubric criterion for high-severity recalls.

Plain-English summary

Plastikon Healthcare LLC has recalled Guaifenesin and Dextromethorphan 200-20 mg/10 mL cups (for institutional use) due to manufacturing process control deviations. The affected product was distributed nationwide in 246,200 units across multiple lots with expiration dates ranging from September 2022 through March 2024.

The products were manufactured under conditions that were not adequately controlled in accordance with Current Good Manufacturing Practice (CGMP) standards. Manufacturing process control deviations could affect product quality and safety.

Affected lots include 20091A (EXP Sep. 2022), 20104A (EXP Nov. 2022), 21017A (EXP Feb. 2023), 21034A and 21036A (EXP Mar. 2023), 21092A (EXP Aug. 2023), 21105A and 21106A (EXP Oct. 2023), 21134A (EXP Dec. 2023), 22007B (EXP Jan. 2024), 22012A (EXP Feb. 2024), and 22016B (EXP Mar. 2024).

Healthcare institutions and affected parties should discontinue use of affected lots and contact Plastikon Healthcare LLC for further guidance.

The recalled product

Product
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
Manufacturer
Plastikon Healthcare LLC
Category
Drug — Cough/Cold Syrup
Hazard
  • manufacturing-control-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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