- Company Announcement Date:
- June 08, 2022
- FDA Publish Date:
- June 08, 2022
- Product Type:
- Reason for Announcement:
Recall Reason Description
Due to microbial contamination
- Company Name:
- Plastikon Healthcare, LLC
- Brand Name:
Plastikon Healthcare, LLC
- Product Description:
Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension
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||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 Use||Occasional 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. 2022||20074A / Jul. 2022||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
|20051A / Aug. 2022
20088A / Sep. 2022
|Packaging||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)||Carton containing 100 single dose cups (10 trays x 10 cups)|
|Product Identification||See image below||See image below||See image below||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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.