The Recall Desk
HighFDA (Drugs)·D-1490-2022·Announced 2022-09-14

Guaifenesin and dextromethorphan liquid medication recalled for manufacturing control issues

Plastikon Healthcare LLC is recalling guaifenesin and dextromethorphan liquid medication (280,500 cups) distributed nationwide due to manufacturing control deviations in production.

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: This is an FDA Class II recall for manufacturing control deviations. Although no illnesses or injuries have been reported, the failure to adequately control manufacturing processes in a drug product qualifies as a risk-of-harm product per the rubric.

Plain-English summary

Plastikon Healthcare LLC is recalling GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL liquid medication distributed nationwide. The product is packaged in 5 mL cups (10 cups per tray, 10 trays per carton) and is labeled for institutional use only.

The recall was initiated because the products were manufactured under conditions that did not adequately control manufacturing processes (CGMP deviations). This means the facility's quality control procedures did not ensure consistent product standards during manufacturing.

The recall affects approximately 280,500 cups across multiple lot numbers with expiration dates ranging from September 2022 through March 2024. Affected lot numbers include 20091A, 20104A, 21013A, 21041A, 21102A, 21121A, 21127A, 22003A, 22007A, and 22016A.

The recalled product

Product
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 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 0904-6844-70
Manufacturer
Plastikon Healthcare LLC
Category
Drug
Hazard
Affected units
280,500

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 (18)

  • Lot # 20091A
  • EXP Sep. 2022
  • 20104A
  • EXP Nov. 2022
  • 21013A
  • EXP Feb. 2023
  • 21041A
  • EXP Apr. 2023
  • 21102A
  • EXP Sep. 2023
  • 21121A
  • 21127A
  • EXP Nov. 2023
  • 22003A
  • 22007A
  • EXP Jan. 2024
  • 22016A
  • EXP Mar. 2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Plastikon Healthcare LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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