Recalls

Contamination found in milk of magnesia and generic Tylenol sent to hospitals, nursing homes

Ten lots of three oral drugs shipped to hospitals, nursing home and clinics nationwide have been recalled for “microbial contamination and failure to properly investigate failed microbial testing.”

That’s in the FDA-posted recall alert from Plastikon Healthcare, manufacturer of the medications for the Major Pharmaceuticals brand.

Here’s what you need to know.

What’s been recalled?

Milk of Magnesia 2400 mg/30 mL Oral Suspension, lot Nos. 20024A and 20025A, expiration March 2022; and lot No. 20041A, expiration May 2022. This is for constipation relief in adults.

Top label of Milk of Magnesia 2400 mg/30 ml
Top label of Milk of Magnesia 2400 mg/30 ml FDA

Acetaminophen (the generic name for Tylenol) 650mg/20.3mL, lot No. 20040A, expiration May 2022. Like Tylenol, this is used for muscle aches, pains, headache, toothache and fever reduction.

Lid of Acetaminophen Oral Solution 650 mb/20.3 mL
Lid of Acetaminophen Oral Solution 650 mb/20.3 mL FDA

Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, lot Nos. 20042A, 20043A, 20045A, 20046A, 20047A, expiration May 2022; and lot No. 21067A, expiration Jun 2023. This is for taking care of stomach problems, including acid indigestion, heartburn and gas.

The lid of Major Pharmaceuticals Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200/Simethicone 120 mg
The lid of Major Pharmaceuticals Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200/Simethicone 120 mg FDA

These were distributed from Major Pharmaceuticals Distribution Center from May 1, 2020, to June 28, 2021.

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Why have these drugs been recalled?

A microbial contamination was found.

Using the above drugs “could result in illness due to intestinal distress, such as diarrhea or abdominal pain,” the recall alert says. “Individuals with a compromised immune system have a higher probability of developing a wide-spread, potentially life-threatening infection when ingesting or otherwise orally exposed to products contaminated by micro-organisms.”

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What should you do now?

Return what you have to the place you bought it. Hospitals, clinics and nursing homes need to tell patients and residents about the recall.

If you have any questions regarding the recall, call Plastikon at 785-330-7109, Monday through Friday, 10 a.m. to 5 p.m., Eastern time, or email sdixon@plastikon.com.

If this or any drug causes a problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.

This story was originally published March 27, 2022 at 5:50 PM with the headline "Contamination found in milk of magnesia and generic Tylenol sent to hospitals, nursing homes."

David J. Neal
Miami Herald
Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.
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