Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: cgmp-deviation
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 →

Same manufacturer · Plastikon Healthcare LLC

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Same hazard · cgmp deviation