Major Pharmaceuticals Milk of Magnesia Recall [US]


Major Pharmaceuticals Milk of Magnesia Recall [US]

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US FlagUS/Silver Spring: Plastikon Healthcare, LLC, a Lawrence, Kansas establishment, recalls certain batch/lots of Major Pharmaceuticals branded Milk of Magnesia 2400 mg/30 mL Oral Osmotic Laxative products, due to suspected risk of high levels of unspecified aerobic bacterial contamination and consequential risk of bacterial infection, severe illness and/or possible life-changing complications, all serious health hazards.

FDA: http://ht.ly/1TJq30pvqkQ

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-issues-voluntary-nationwide-recall-milk-magnesia-oral-suspension-2400-mg30-ml

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Oral Laxative products are subject to this recall:

  • Major Pharmaceuticals Milk of Magnesia Oral Osmotic Laxative products, sold in cartons containing one hundred (100) single dose cups (10 trays by 10 cups) of 2400 mg/30 mL laxative suspension with batch/lots of 19027D and 19027E, a carton NDC designation of 0904-6846-73 and an expiry date of 2021 July

Please consult the photograph above for details of the drug’s packaging, design and retail presentation. Additional images of the recalled Milk of Magnesia Oral Osmotic Laxative products can be found on the Web site above.

According to the FDA, Plastikon Healthcare has recalled certain batch/lots of Milk of Magnesia Oral Suspension Laxative to the patient level because these product lots did not meet Plastikon’s in-house microbiological specification for Total Aerobic Microbial Count.

This product is packaged for institutional use and is sold to clinics and hospitals, the patient population most likely to use the product are likely immunocompromised. People 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. You should neither serve nor consume the recalled Oral Osmotic Laxative product identified above.

==> Never stop taking your prescription medications, including Oral Laxative products, without the knowledge and approval of your personal physician or other MD familiar with your medical history, current health status and other drugs, medications and supplements you may be consuming. Failure to do so, may result in a serious drug interaction, side effect, complication, personal injury and/or death.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination. If in doubt about the safety of any drug or supplement, return it to your wholesaler for refund or toss it out in your medical waste.

If you believe you have purchased or have in your possession any of the recalled Oral Laxative products, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the Laxative products to the store where you purchased it for a full refund.

The affected lots were distributed to Major Pharmaceuticals Distribution Center (a drug wholesaler), who may have shipped to clinics, hospitals and healthcare providers in the United States throughout August 2019.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat bacterial contamination.

==> To see other recalls and notifications caused by contaminated, adulterated or mislabeled Oral Laxative products, please search for “laxative” or more generically, “drug” using the Search Box at the top of this page.

Anyone with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Please inform healthcare professionals within your organization of this recall. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify these patients regarding the recall. For additional assistance, call Plastikon Healthcare at 1-785-330-7100 from 8:00 AM to 5:00 PM. Central Standard Time, Monday to Friday.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Plastikon Healthcare, LLC, please search for “Plastikon” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Major Pharmaceuticals brand name, please search for “Major Pharma” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 12022-2019
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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