← Every firm
Plastikon Healthcare LLC FDA Recalls
24 recalls on file across drugs, 6 of them Class I and 0 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, Class IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For InsClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, pClass IJun 7, 2022Microbial Contamination of Non-Sterile Products. |
| MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, Class IJun 7, 2022Microbial Contamination of Non-Sterile Products |
| Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For InstiClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For InsClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packageClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For InstClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, pClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL inClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For InstitutionaClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For InstClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups peClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For InstitClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups peClass IJun 7, 2022Microbial Contamination of Non-Sterile Products. |
| CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For InstituClass IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, Class IIJun 7, 2022CGMP Deviations: products manufactured under conditions whic |
| MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, Class IJun 7, 2022Microbial Contamination of Non-Sterile Products. |
| MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per cartonClass IMar 24, 2022Microbial Contamination of Non-Sterile Products |
| Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trClass IMar 24, 2022Microbial Contamination of Non-Sterile Products |
| MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per cartonClass IIMar 24, 2022CGMP Deviations: Failure to properly investigate failed micr |
| Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For InstitutionaClass IIMar 24, 2022CGMP Deviations: Failure to properly investigate failed micr |
| Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trClass IIMar 24, 2022CGMP Deviations: Failure to properly investigate failed micr |