United States
Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic and patient level. The products are being recalled due to microbial contamination and failure to properly investigate failed microbial testing. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 5/1/2020 and 6/28/2021, who shipped to hospitals, nursing homes, and clinics nationwide.Â
This product potentially could result in illness due to intestinal distress, such as diarrhea or abdominal pain. 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.
To date, Plastikon has not received any customer complaints related to microbial concerns or reports of adverse events related to this recall. Product indication, lot numbers, expiration dates and NDC information are listed below. The product is packaged for institutional use and is sold to clinics and hospitals nationwide in single use cups with a foil lid. The products are private labeled for Major Pharmaceuticals.
Recalled products:
- Product Name: Milk of Magnesia 2400 mg/30 mL Oral Suspension
Indications for use: Milk of Magnesia 2400 mg/ 30 mL is indicated for the occasional relief of constipation
(irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor.
Lot/exp.
20024A/Mar 2022
20025A/Mar 2022
20041A/May 2022
NDC: 0904-6846-73
Type of Packaging: Carton containing 100 single dose cups (10 trays x 10 cups)
- Product name: Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/ Simethicone 120mg per 30 mL
Indications for use: Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL is indicated for relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating commonly referred to as gas.
Lot/exp.
20042A/May 2022
20043A/May 2022
20045A/May 2022
20046A/May 2022
20047A/May 2022
21067A/Jun 2023
NDC: 0904-6838-73
Type of Packaging: Carton containing 100 single dose cups (10 trays x 10 cups)
- Product name: Acetaminophen 650mg/ 20.3mL
Indications for use: Acetaminophen 650mg/ 20.3mL indicated for temporarily relief of minor aches and pains due to, minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, toothache, and temporarily reduction of fever.
Lot/exp. 20040A/May 2022
NDC: 0904-6820-76
Type of Packaging: 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 has notified 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.
Patients are advised to contact their doctor or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Company name: Plastikon Healthcare, LLC
Brand name: Major Pharmaceuticals
Product recalled: Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL
Reason of the recall: Microbial Contamination
FDA Recall date: March 24, 2022
Source:
www.fda.gov
