The Recall Desk
SevereFDA (Drugs)·D-1477-2022·Announced 2022-09-14

Milk of Magnesia USP Recalled for Microbial Contamination Nationwide

Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to microbial contamination in non-sterile products. Lot 20074A, distributed nationwide for institutional use, should not be used.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum Severe rating per the severity rubric. Microbial contamination of medications presents serious health risks, though no illnesses or deaths are reported in the source material.

Plain-English summary

Plastikon Healthcare LLC is recalling Milk of Magnesia USP (magnesium hydroxide, 2400 mg/10 mL) intended for institutional use. The recalled product is lot 20074A with expiration July 2022. Approximately 7,700 cups were distributed nationwide.

The product has been recalled due to microbial contamination in the non-sterile formulation. Microbial contamination in oral medications poses a potential health risk to patients who consume the product.

Healthcare facilities that received this product should identify inventory from lot 20074A and cease use immediately. Affected healthcare providers should contact Plastikon Healthcare LLC or the FDA for instructions regarding return or disposal of the product.

The recalled product

Product
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 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 0904-6840-72.
Manufacturer
Plastikon Healthcare LLC
Hazard
  • microbial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 20074A
  • EXP Jul. 2022

Distribution

Distributed nationwide across the United States.