FDAClass ISeptember 18, 2019

Milk of Magnesia USP recall: Sterility Concern

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.

Why was Milk of Magnesia USP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: 19027D, 19027E, Exp 07/21

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.
Recalling firm
Plastikon Healthcare LLC
Quantity
1,433 cases
Distribution
One distributor who further distributed Nationwide in the USA.
Recall date
September 18, 2019
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls