Plastikon Healthcare LLC recalls
15 recalls on record · 4 rated Critical · FDA
Every recall we have on record for Plastikon Healthcare LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray,…
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per…
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10…
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per…
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups…
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30…
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5…
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray,…
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups…
Microbial Contamination of Non-Sterile Products.
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30…
Microbial Contamination of Non-Sterile Products.
CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray,…
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup,…
Microbial Contamination of Non-Sterile Products
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10…
Microbial Contamination of Non-Sterile Products
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10…
CGMP Deviations: Failure to properly investigate failed microbial testing.
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup,…
CGMP Deviations: Failure to properly investigate failed microbial testing.