FDA (Drugs) recall action 90398

Plastikon Healthcare LLC recalled 19 products on 2022-09-14

The FDA (Drugs) publishes a recall like this one as 19 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 19 pages.

Products: 19
Announced: 2022-09-14
Critical: 1
Units: 7,300,218

Why these products were recalled

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Microbial Contamination of Non-Sterile Products.

Microbial Contamination of Non-Sterile Products

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–19 of 19

ModerateFDA (Drugs)··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
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Distribution
0 states
HighFDA (Drugs)··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
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0 states
SevereFDA (Drugs)··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
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0 states
HighFDA (Drugs)··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
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Distribution
0 states
ModerateFDA (Drugs)··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
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0 states
HighFDA (Drugs)··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
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Distribution
0 states
ModerateFDA (Drugs)··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
Distribution
0 states
SevereFDA (Drugs)··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.
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Distribution
0 states
HighFDA (Drugs)··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
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0 states
HighFDA (Drugs)··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
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0 states
HighFDA (Drugs)··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.
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Distribution
0 states
HighFDA (Drugs)··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
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0 states
HighFDA (Drugs)··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
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0 states
HighFDA (Drugs)··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
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0 states
ModerateFDA (Drugs)··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.
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0 states
SevereFDA (Drugs)··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
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0 states
HighFDA (Drugs)··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
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0 states
CriticalFDA (Drugs)··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.
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Distribution
0 states
HighFDA (Drugs)··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
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0 states