🍔 Food 💊 Drugs 🏥 Medical Devices
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 Class II

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

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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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 Class II

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

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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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 Class II

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

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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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 0904-6839-73 Class II

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

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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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 Class II

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

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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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. Class II

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

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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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. Class II

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

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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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 0904-6839-73 Class I

Reason: Microbial Contamination of Non-Sterile Products.

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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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 Class I

Reason: Microbial Contamination of Non-Sterile Products.

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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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. Class I

Reason: Microbial Contamination of Non-Sterile Products.

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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