Plastikon Healthcare recalls
FDA enforcement reports naming Plastikon Healthcare LLC as the recalling firm.
- Recall reports
- 25
- Class I (serious)
- 7
- Most recent report
- Sep 14, 2022
- Sep 14, 2022CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorph…Drug · Plastikon Healthcare LLCCGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.Class II
- Sep 14, 2022Diphenhydramine HCl Oral Solution 12Drug · Plastikon Healthcare LLCCGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.Class II
- Sep 14, 2022Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tr…Drug · Plastikon Healthcare LLCCGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.Class II
- Sep 14, 2022GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per t…Drug · Plastikon Healthcare LLCCGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.Class II
- Sep 14, 2022GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tr…Drug · Plastikon Healthcare LLCCGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.Class II
- Sep 14, 2022CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12Drug · Plastikon Healthcare LLCCGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.Class II
- Sep 14, 2022CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per…Drug · Plastikon Healthcare LLCCGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.Class II
- Sep 14, 2022MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cup…Drug · Plastikon Healthcare LLCMicrobial Contamination of Non-Sterile ProductsClass I
- Sep 14, 2022MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cup…Drug · Plastikon Healthcare LLCMicrobial Contamination of Non-Sterile Products.Class I
- Sep 14, 2022Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL,…Drug · Plastikon Healthcare LLCMicrobial Contamination of Non-Sterile Products.Class I
- Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30…
- MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cup…
- MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cup…
- Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL,…
- Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30…
- Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 t…
- Acetaminophen Oral Solution, 325 mg / 10
- Acetaminophen Oral Solution 650 mg / 20
- CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray…
- MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 c…
- Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, pa…
- Acetaminophen Oral Solution, USP 650mg/ 20
- MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 c…
- Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, pa…
- Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups,…
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