Elevated risk U.S. Food and Drug Administration

Major Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone recall: Due to microbial contamination

Recall published 4+ years ago

Due to microbial contamination

Major Prescription & OTC drugs — recalled prescription & otc drugsMajor Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Major Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Major Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

What the notice says: Risk Statement: Administration or use of oral drug products with microbial contamination could potentially result in increased infections that may require medical intervention.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
June 8, 2022
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Major
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension

What the company announced

FOR IMMEDIATE RELEASE – 6/07/2022 – Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral Suspension, and two (2) lots of Magnesium Hydroxide 2400 mg/Aluminum Hydroxide 2400 mg/Simethicone 240 mg per 30 mL Oral Suspension to the consumer level. The products are being recalled due to microbial contamination.

Risk Statement: Administration or use of oral drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Patients with compromised immune systems, such as patients in hospitals and nursing homes, have a higher probability of developing potentially life-threatening infections after taking a contaminated product. To date, Plastikon Healthcare has not received any reports of adverse events or injuries related to this recall.

Product indication, lot numbers, expiration dates, and NDC information are listed in the table below. The products are packaged for institutional use and are sold to clinics and hospitals nationwide in single use cups with a foil lid. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 7/1/2020 and 10/31/2021, who shipped to hospitals, nursing homes, and clinics nationwide. The products are private labeled for Major Pharmaceuticals.

  • Product Name: Indications for Use · Milk of Magnesia 2400 mg / 30 mL Oral Suspension: Occasional relief of constipation (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor. · Milk of Magnesia 2400 mg / 10 mL Oral Suspension: Occasional relief of constipation (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor. · Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension: Relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating commonly referred to as gas. · Magnesium Hydroxide 2400 mg / Aluminum Hydroxide 2400 mg / Simethicone 240 mg per 30 mL Oral Suspension: Relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating commonly referred to as gas.
  • Product Name: Lot/Exp. · Milk of Magnesia 2400 mg / 30 mL Oral Suspension: 20071A / Jul. 2022 · Milk of Magnesia 2400 mg / 10 mL Oral Suspension: 20074A / Jul. 2022 · Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension: 21103A / Sep. 2023 20046A / May. 2022 20079A / Aug. 2022 20080A / Aug. 2022 20081A / Aug. 2022 21057A / May. 2023 21059A / May. 2023 21095A / Sep. 2023 21096A / Sep. 2023 21099A / Sep. 2023 21115A / Oct. 2022 · Magnesium Hydroxide 2400 mg / Aluminum Hydroxide 2400 mg / Simethicone 240 mg per 30 mL Oral Suspension: 20051A / Aug. 2022 20088A / Sep. 2022
  • Product Name: NDC · Milk of Magnesia 2400 mg / 30 mL Oral Suspension: 0904-6846-73 · Milk of Magnesia 2400 mg / 10 mL Oral Suspension: 0904-6840-72 · Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension: 0904-6838-73 · Magnesium Hydroxide 2400 mg / Aluminum Hydroxide 2400 mg / Simethicone 240 mg per 30 mL Oral Suspension: 0904-6839-73
  • Product Name: Packaging · Milk of Magnesia 2400 mg / 30 mL Oral Suspension: Carton containing 100 single dose cups (10 trays x 10 cups) · Milk of Magnesia 2400 mg / 10 mL Oral Suspension: Carton containing 100 single dose cups (10 trays x 10 cups) · Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension: Carton containing 100 single dose cups (10 trays x 10 cups) · Magnesium Hydroxide 2400 mg / Aluminum Hydroxide 2400 mg / Simethicone 240 mg per 30 mL Oral Suspension: Carton containing 100 single dose cups (10 trays x 10 cups)
  • Product Name: Product Identification · Milk of Magnesia 2400 mg / 30 mL Oral Suspension: See image below · Milk of Magnesia 2400 mg / 10 mL Oral Suspension: See image below · Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension: See image below · Magnesium Hydroxide 2400 mg / Aluminum Hydroxide 2400 mg / Simethicone 240 mg per 30 mL Oral Suspension: See image below

Plastikon Healthcare is notifying its direct customers via a recall letter to arrange for return of any recalled product. Anyone with an existing inventory of the lots which are being recalled should stop use and distribution, and quarantine immediately. Return all quarantined product to the place of purchase. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify patients regarding the recall.

Consumers with questions regarding this recall can contact Plastikon Healthcare by phone at (785) 330-7109 or by e-mail at [email protected] Monday through Friday from 9 am to 4 pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 2400 mg
  • 10 mL
  • 30 mL
  • 1200 mg
  • 120 mg
  • 240 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

Major — This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

  1. Stop eating it and keep it separate from other food.
  2. Read the official notice for the organism named — the advice for Listeria, Salmonella and hepatitis A is not the same.
  3. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  4. Bag and bin it, or return it to the store for a refund.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Plastikon Healthcare, LLC — Consumers: Plastikon Healthcare, 785-330-7109, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Major prescription & otc drugs recalled?

Due to microbial contamination Risk Statement: Administration or use of oral drug products with microbial contamination could potentially result in increased infections that may require medical intervention.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls