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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 3361–3380 of 17,723 recalls

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · Drug

View details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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.

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class ITerminated

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.

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products.

June 7, 2022 · DrugView details →

Class ITerminated

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

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products.

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class ITerminated

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.

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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.

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class ITerminated

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

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products.

June 7, 2022 · DrugView details →

Class IITerminated

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

Plastikon Healthcare LLC

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

June 7, 2022 · DrugView details →

Class IITerminated

Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8

PD-Rx Pharmaceuticals, Inc.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

June 6, 2022 · DrugView details →

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