FDA recall D-1879-2019

Product

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.

Distribution

One distributor who further distributed Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2019-08-30

Report date

2019-09-18

Termination date

2020-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lawrence, KS, United States

Primary source

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