The Recall Desk
SevereFDA (Drugs)·D-1478-2022·Announced 2022-09-14

Antacid Medication Recalled Nationwide for Microbial Contamination Risk

Plastikon Healthcare LLC is recalling 220,500 cups of antacid containing magnesium hydroxide and aluminum hydroxide due to microbial contamination.

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 recall classification mandates a minimum severity score of 4 per the rubric. The source does not report any illnesses, injuries, or deaths, which would elevate this to a score of 5 (Critical).

Plain-English summary

Plastikon Healthcare LLC is recalling Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, and Simethicone 120 mg per 30 mL antacid product distributed for institutional use.

The recall is due to microbial contamination identified in the non-sterile product. A total of 220,500 cups have been distributed nationwide. The affected lot numbers are 20076A (expiring July 2022), 20079A and 20081A (expiring August 2022), 21096A (expiring October 2022), and 21115A and 21103A (expiring September 2022).

This is a Class I recall, the most serious FDA classification for drugs.

The recalled product

Product
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 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 0904-6838-73
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 (10)

  • Lot# 20076A
  • EXP Jul. 2022
  • 20079A
  • 20081A
  • EXP Aug. 2022
  • 21096A
  • EXP Oct. 2022
  • 21115A
  • 21103A
  • EXP Sep. 2022.

Distribution

Distributed nationwide across the United States.