The Recall Desk
HighFDA (Drugs)·D-1480-2022·Announced 2022-09-14

FDA Recalls Milk of Magnesia USP for Manufacturing Control Deviations

Plastikon Healthcare LLC is recalling 502,600 cups of Milk of Magnesia USP due to manufacturing process control deviations. Consumers should discontinue use and consult their healthcare provider if concerned.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for manufacturing process control deviations. No illnesses or injuries reported, but CGMP violations represent potential risk to product quality and user safety, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Plastikon Healthcare LLC is recalling 502,600 cups of Milk of Magnesia USP (2400 mg/30 mL magnesium hydroxide) distributed nationwide in the United States. The recall is due to manufacturing process control deviations—the product was manufactured under conditions where manufacturing processes were not adequately controlled.

This product was intended for institutional use only. The affected lot numbers and their expiration dates are: lots 20072A and 20075A (July 2022), 20087A (August 2022), 20089A and 20090A (September 2022), 20100A and 20102A (October 2022), 20106A and 20107A (November 2022), 20109A (December 2022), 21010A (January 2023), 21028A, 21030A, and 21032A (March 2023), 21045A and 21046A (April 2023), 21054A (May 2023), and 21078A, 21079A, 21085A, and 21088A (July–August 2023).

Institutions and consumers should immediately stop using any of the recalled product. If you have concerns about having used this product, contact your healthcare provider or call poison control for guidance.

The recalled product

Product
MILK OF MAGNESIA USP, 2400 mg/30 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 0904-6846-73.
Manufacturer
Plastikon Healthcare LLC
Category
Drug
Hazard
  • manufacturing-deviation

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 (20)

  • Lot # 20072A
  • 20075A
  • EXP Jul. 2022
  • 20087A
  • EXP Aug. 2022
  • 20089A
  • 20090A
  • EXP Sep. 2022
  • 20100A
  • 20102A
  • EXP Oct. 2022
  • 20106A
  • 20107A EXP Nov. 2022
  • 20109A
  • EXP Dec. 2022
  • 21010A
  • EXP Jan. 2023
  • 21028A
  • 21030A
  • 21032A

Distribution

Distributed nationwide across the United States.

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