Home / Companies / Plastikon Healthcare LLC

Plastikon Healthcare LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Plastikon Healthcare LLC has 25 FDA recalls (7 Class I), 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Plastikon Healthcare LLC, the most recent on Apr 20, 2022.

What these totals cover: FDA records filed under the name "Plastikon Healthcare LLC" and its spelling variant "Plastikon Healthcare".

Latest recall: D-1494-2022 · Class II · Jun 7, 2022
Latest inspection: Apr 30, 2024 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	25 (7 Class I)	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Plastikon Healthcare LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	1	0	0	0	0
2022	0	0	1	24	6
2021	1	1	0	0	0
2020	0	0	0	0	0
2019	0	0	0	1	1
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Reviewing Plastikon Healthcare LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Plastikon Healthcare LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Plastikon Healthcare LLC FDA Warning Letters

1 warning letter on Apr 20, 2022.

Issued	Subject	Issuing office	Close-out letter
Apr 20, 2022 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent recalls

25 recall records from Aug 30, 2019 to Jun 7, 2022. Showing the 20 most recent. View all 25 recall records

Number	Class	Product	Date
D-1494-2022	Class II	CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5…	Jun 7, 2022
D-1493-2022	Class II	CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04…	Jun 7, 2022
D-1477-2022	Class I	MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray…	Jun 7, 2022
D-1489-2022	Class II	Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays…	Jun 7, 2022
D-1487-2022	Class II	CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per…	Jun 7, 2022
D-1476-2022	Class I	MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray…	Jun 7, 2022
D-1479-2022	Class I	Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral…	Jun 7, 2022
D-1491-2022	Class II	GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays…	Jun 7, 2022
D-1488-2022	Class II	Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays…	Jun 7, 2022
D-1485-2022	Class II	Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays…	Jun 7, 2022
D-1482-2022	Class II	Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup…	Jun 7, 2022
D-1486-2022	Class II	Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays…	Jun 7, 2022
D-1484-2022	Class II	Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per…	Jun 7, 2022
D-1490-2022	Class II	GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays…	Jun 7, 2022
D-1481-2022	Class II	MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray…	Jun 7, 2022
D-1480-2022	Class II	MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray…	Jun 7, 2022
D-1478-2022	Class I	Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup…	Jun 7, 2022
D-1492-2022	Class II	CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL)…	Jun 7, 2022
D-1483-2022	Class II	Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral…	Jun 7, 2022
D-0867-2022	Class I	MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray…	Mar 24, 2022

Recent FDA inspections

5 inspections from Nov 22, 2013 to Apr 30, 2024.

Date	Site	Product	Classification	FEI
Apr 30, 2024	Lawrence, KS	Drugs	No Action Indicated (NAI)	3009840089
Jan 12, 2023	Lawrence, KS	Food/Cosmetics	Voluntary Action Indicated (VAI)	3009840089
Nov 4, 2021	Lawrence, KS	Drugs	Official Action Indicated (OAI)	3009840089
Oct 28, 2016	Lawrence, KS	Devices	No Action Indicated (NAI)	3009840089
Nov 22, 2013	Lawrence, KS	Devices	No Action Indicated (NAI)	3009840089

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Plastikon Healthcare LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 20, 2022.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3009840089	Lawrence, KS	5	Apr 30, 2024

Plastikon Healthcare LLC and the FDA: common questions

Has Plastikon Healthcare LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Plastikon Healthcare LLC. The most recent is dated Apr 20, 2022.

Has Plastikon Healthcare LLC received an FDA Form 483?

FDA has not published a Form 483 for "Plastikon Healthcare LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Plastikon Healthcare LLC?

The most recent FDA inspection on file ended Apr 30, 2024 at Lawrence, KS and was classified NAI. FDA has 5 inspections of Plastikon Healthcare LLC on file, 1 of them classified OAI (official action indicated).

Has Plastikon Healthcare LLC had an FDA recall?

Yes. Plastikon Healthcare LLC has 25 FDA recalls on record, 7 of them Class I, the most serious class. The most recent started Jun 7, 2022.

Need more than this page shows? Ask about Plastikon Healthcare LLC in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.