Jun 8, 2022 FDA company announcement
Due to microbial contamination
Not supplied Reported terminated
Distribution: Product indication, lot numbers, expiration dates, and NDC information are listed in the table below. The products are packaged for institutional use and are sold to clinics and...
Official source for Major: Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension Jun 7, 2022 FDA drug enforcement
Microbial Contamination of Non-Sterile Products
Class I Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray... Jun 7, 2022 FDA drug enforcement
Microbial Contamination of Non-Sterile Products.
Class I Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray... Jun 7, 2022 FDA drug enforcement
Microbial Contamination of Non-Sterile Products.
Class I Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup,... Jun 7, 2022 FDA drug enforcement
Microbial Contamination of Non-Sterile Products.
Class I Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral S... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup,... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral S... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per c... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 tr... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays ... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 tray... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 tra... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 tr... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 tra... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL)... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04... Jun 7, 2022 FDA drug enforcement
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II Reported terminated
Distribution: Distributed Nationwide in the USA
Official source for CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg pe...