Manufacturer

Plastikon Healthcare LLC

25 recalls in our database name Plastikon Healthcare LLC as the manufacturing or recalling firm.

What the numbers show

Total: 25
Critical: 2
Severe: 5
Most recent: 2022-09-14

Of the 25 recalls from Plastikon Healthcare LLC we have scored against our rubric, 2 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 25

CriticalFDA (Drugs)·D-1476-2022·2022-09-14
Milk of Magnesia Recalled Nationwide for Microbial Contamination
Plastikon Healthcare LLC has recalled Milk of Magnesia USP nationwide due to microbial contamination in non-sterile products. The affected lot (20071A) included approximately 24,400 institutional-use cups.
Product
MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 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 0904-6846-73.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1478-2022·2022-09-14
Antacid Medication Recalled Nationwide for Microbial Contamination Risk
Plastikon Healthcare LLC is recalling 220,500 cups of antacid containing magnesium hydroxide and aluminum hydroxide due to microbial contamination.
Product
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 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 0904-6838-73
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1477-2022·2022-09-14
Milk of Magnesia USP Recalled for Microbial Contamination Nationwide
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to microbial contamination in non-sterile products. Lot 20074A, distributed nationwide for institutional use, should not be used.
Product
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 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 0904-6840-72.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1479-2022·2022-09-14
Antacid Oral Suspension Recalled Nationwide for Microbial Contamination
Plastikon Healthcare LLC is recalling an antacid oral suspension distributed nationwide due to microbial contamination. Affected lots 20051A (exp. Aug. 2022) and 20088A (exp. Sep. 2022) should not be used.
Product
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1494-2022·2022-09-14
Children's Cough Medicine Recalled for Manufacturing Control Deficiency
CORRECTDOSE Children's Cough & Chest Congestion DM is being recalled nationwide due to manufacturing process control deviations that did not meet required quality standards.
Product
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1489-2022·2022-09-14
Diphenhydramine HCl Oral Solution Recalled for Manufacturing Process Deviations
Plastikon Healthcare LLC is recalling 349,100 cups of Diphenhydramine HCl Oral Solution due to manufacturing process control deviations. The product was distributed nationwide for institutional use only.
Product
Diphenhydramine HCl Oral Solution, 25 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 0904-6741-72
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1490-2022·2022-09-14
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.
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1484-2022·2022-09-14
Acetaminophen Oral Solution 160 mg Recalled for Manufacturing Control Deviations
Acetaminophen Oral Solution 160 mg/5 mL (290,270 cups) recalled nationwide due to CGMP manufacturing control deviations. Product was distributed to institutional healthcare facilities.
Product
Acetaminophen Oral Solution 160 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 0904-6738-70
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1486-2022·2022-09-14
Acetaminophen Oral Solution Recalled for Manufacturing Process Control Failures
Plastikon Healthcare LLC is recalling acetaminophen oral solution (650 mg per 20.3 mL cup) distributed nationwide due to manufacturing process control failures.
Product
Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 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 0904-6820-76
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1487-2022·2022-09-14
Calcium Carbonate Oral Suspension Recalled Due to Manufacturing Control Deviations
Plastikon Healthcare recalls 49,280 cups of Calcium Carbonate Oral Suspension (1250 mg/5 mL) distributed nationwide due to manufacturing process control failures during production.
Product
CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1480-2022·2022-09-14
FDA Recalls Milk of Magnesia USP for Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling 502,600 cups of Milk of Magnesia USP due to manufacturing process control deviations. Consumers should discontinue use and consult their healthcare provider if concerned.
Product
MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 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 0904-6846-73.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1491-2022·2022-09-14
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.
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1493-2022·2022-09-14
CORRECTDOSE Children's Pain Relief and Fever Reducer Acetaminophen Recalled for Manufacturing Control Violations
CORRECTDOSE Children's Fever Reducer (160 mg/5 mL acetaminophen) has been recalled due to manufacturing control deviations. The recall affects 1,464 units distributed nationwide.
Product
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1488-2022·2022-09-14
Diphenhydramine Solution Recalled Due to Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution nationwide due to manufacturing control deficiencies that did not meet Current Good Manufacturing Practice standards.
Product
Diphenhydramine HCl Oral Solution 12.5 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 0904-6740-70
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1492-2022·2022-09-14
CORRECTDOSE Children's Allergy Relief Recalled Due to Manufacturing Process Control Deviations
CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.
Product
CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1483-2022·2022-09-14
Magnesium Hydroxide and Aluminum Hydroxide Oral Suspension Recalled for Manufacturing Control Issues
Plastikon Healthcare LLC is recalling an antacid oral suspension due to manufacturing control deviations. No illnesses have been reported.
Product
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1481-2022·2022-09-14
Milk of Magnesia Recalled for Manufacturing Process Control Issues
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to manufacturing process control deviations affecting approximately 92,200 cups distributed nationwide.
Product
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 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 0904-6840-72.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1482-2022·2022-09-14
Antacid Suspension Recalled Due to Manufacturing Process Control Deviations
Plastikon Healthcare LLC is recalling multiple lots of antacid suspension because manufacturing processes were not adequately controlled. The product was distributed nationwide to institutions.
Product
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 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 0904-6838-73
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1485-2022·2022-09-14
Acetaminophen Oral Solution Recalled Due to Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution nationwide because manufacturing quality controls were not adequately maintained. Affected product was distributed to institutional healthcare settings.
Product
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 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 0904-6739-71
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0868-2022·2022-05-25
Antacid suspension product recalled due to microbial contamination
Plastikon Healthcare LLC is recalling 23,300 antacid suspension cups due to microbial contamination. The product was distributed in Indiana for institutional use.
Product
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0867-2022·2022-05-25
Milk of Magnesia USP Recalled for Microbial Contamination
Plastikon Healthcare LLC is recalling Milk of Magnesia USP (2400 mg/30 mL) distributed in Indiana due to microbial contamination in this non-sterile product. The FDA classified this as a Class I recall.
Product
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0869-2022·2022-05-25
Acetaminophen Oral Solution Recalled Due to Manufacturing Quality Control Failure
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution due to failure to properly investigate failed microbial testing. The recall affects 121,800 unit dose cups distributed in Indiana.
Product
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0870-2022·2022-05-25
Milk of Magnesia Institutional Units Recalled for Manufacturing Quality Deviation
Plastikon Healthcare LLC is recalling 5,400 unit doses of Milk of Magnesia USP (Lot 20041A, exp. May 2022) due to failure to properly investigate failed microbial testing during manufacturing. The product was distributed in Indiana for further distribution nationwide.
Product
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0871-2022·2022-05-25
Antacid Suspension Recalled for Failed Microbial Testing
Plastikon Healthcare LLC is recalling antacid suspension due to manufacturing quality control failures. The company failed to properly investigate results from microbial testing.
Product
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-1879-2019·2019-09-18
Plastikon Recalls Milk of Magnesia Unit Dose Cups for Microbial Contamination
Plastikon Healthcare LLC is recalling specific lots of Milk of Magnesia unit dose cups because they failed bioburden testing for Total Aerobic Microbial Count.
Product
Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
Category
Drug
Distribution
Distributed nationwide