Plastikon Healthcare

25 recalls •

• Categories: Prescription Drugs, Other Drugs, Over-the-Counter

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

Class I - Dangerous

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

Jun 7, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jun 7, 2022 Prescription Drugs Nationwide View Details →

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 I - Dangerous

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

Jun 7, 2022 Prescription Drugs Nationwide View Details →

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 I - Dangerous

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

Jun 7, 2022 Prescription Drugs Nationwide View Details →

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 - Dangerous

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

Jun 7, 2022 Other Drugs Nationwide View Details →

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 - Dangerous

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

Jun 7, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jun 7, 2022 Over-the-Counter Nationwide View Details →

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 I - Dangerous

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

Jun 7, 2022 Prescription Drugs Nationwide View Details →

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 - Dangerous

Microbial Contamination of Non-Sterile Products.

Jun 7, 2022 Other Drugs Nationwide View Details →

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 - Dangerous

Microbial Contamination of Non-Sterile Products.

Jun 7, 2022 Other Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jun 7, 2022 Prescription Drugs Nationwide View Details →

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 - Dangerous

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

Jun 7, 2022 Other Drugs Nationwide View Details →

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 I - Dangerous

Microbial Contamination of Non-Sterile Products

Jun 7, 2022 Other Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jun 7, 2022 Over-the-Counter Nationwide View Details →

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 I - Dangerous

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

Jun 7, 2022 Other Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jun 7, 2022 Other Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jun 7, 2022 Other Drugs Nationwide View Details →

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 - Dangerous

Microbial Contamination of Non-Sterile Products.

Jun 7, 2022 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Jun 7, 2022 Other Drugs Nationwide View Details →

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

Class I - Dangerous

Microbial Contamination of Non-Sterile Products

Mar 24, 2022 Other Drugs View Details →

MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Class I - Dangerous

Microbial Contamination of Non-Sterile Products

Mar 24, 2022 Other Drugs View Details →

Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.

Class I - Dangerous

CGMP Deviations: Failure to properly investigate failed microbial testing.

Mar 24, 2022 Prescription Drugs View Details →

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

Class I - Dangerous

CGMP Deviations: Failure to properly investigate failed microbial testing.

Mar 24, 2022 Other Drugs View Details →

MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Class I - Dangerous

CGMP Deviations: Failure to properly investigate failed microbial testing.

Mar 24, 2022 Other Drugs View Details →

Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.

Aug 30, 2019 Other Drugs Nationwide View Details →