PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: September 18, 2019 Initiated: August 30, 2019 #D-1879-2019

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Plastikon Healthcare LLC
Units Affected
1,433 cases
Distribution
One distributor who further distributed Nationwide in the USA.
Location
Lawrence, KS

Frequently Asked Questions

What product was recalled?
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.. Recalled by Plastikon Healthcare LLC. Units affected: 1,433 cases.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 18, 2019. Severity: Critical. Recall number: D-1879-2019.