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Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

Microbial contamination

Company Name:
Plastikon Healthcare, LLC
Brand Name:

Brand Name(s)

Product Description:

Product Description

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


Company Announcement

8/3/2022 – Lawrence, Kansas – Plastikon Healthcare, LLC is issuing an update to the voluntary recall initiated on June 3, 2022.  The recall has been expanded to include Lot 20076A of Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension. This lot was previously subject to a retail level recall and has been added to the current consumer level recall based on updated microorganism speciation data from third-party testing.

The updated recall includes 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, twelve (12) 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 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

Milk of Magnesia
2400 mg / 30 mL
Oral Suspension

Milk of Magnesia
2400 mg / 10 mL
Oral Suspension

Magnesium
Hydroxide 1200 mg / Aluminum
Hydroxide 1200 mg
/ Simethicone 120 mg per 30 mL Oral
Suspension

Magnesium Hydroxide 2400 mg / Aluminum
Hydroxide 2400 mg / Simethicone
240 mg per 30 mL Oral Suspension

Indications for UseOccasional relief of constipation
(irregularity) in adults and children
12 years and older or for children under
12 as recommended by a doctor.
Occasional relief of constipation
(irregularity) in adults and children
12 years and older or for children under
12 as recommended by a doctor.
Relief of acid indigestion,
heartburn, sour
stomach, upset
stomach due to these
symptoms, pressure and bloating
commonly referred to as gas.
Relief of acid indigestion,
heartburn, sour
stomach, upset
stomach due to these
symptoms, pressure and bloating
commonly referred to as gas.
Lot/Exp.20071A / Jul. 202220074A / Jul. 202221103A / Sep. 2023
20046A / May 2022
20076A / Jul. 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
20051A / Aug. 2022 20088A / Sep. 2022
NDC0904-6846-730904-6840-720904-6838-730904-6839-73
PackagingCarton containing
100 single dose cups
(10 trays x 10 cups)
Carton containing
100 single dose cups
(10 trays x 10 cups)
Carton containing 100 single dose cups (10 trays x 10 cups)Carton containing
100 single dose cups
(10 trays x 10 cups)

Plastikon Healthcare places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.  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
  • Regular Mail or Fax: Download form 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.

Link to Initial Press Release


Company Contact Information

Go to Source
Author: FDA

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