PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: September 14, 2022 Initiated: June 7, 2022 #D-1479-2022

Product Description

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

Reason for Recall

Microbial Contamination of Non-Sterile Products.

Details

Recalling Firm
Plastikon Healthcare LLC
Units Affected
43,200 cups
Distribution
Distributed Nationwide in the USA
Location
Lawrence, KS

Frequently Asked Questions

What product was recalled?
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. Recalled by Plastikon Healthcare LLC. Units affected: 43,200 cups.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 14, 2022. Severity: Critical. Recall number: D-1479-2022.