FDA-Drug2019-09-18Class I

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.

Plastikon Healthcare LLC
Hazard

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

Sold states
One distributor who further distributed Nationwide in the USA.
Affected count
1,433 cases
Manufactured in
3780 Greenway Cir, Lawrence, KS, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1879-2019

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