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Tempo FDA Alerts

The FDA Alerts below may be specifically about Tempo or relate to a group or class of drugs which include Tempo.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Tempo

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

August 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 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
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
NDC 0904-6846-73 0904-6840-72 0904-6838-73 0904-6839-73
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)

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 dixon@plastikon.com 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

Source: FDA


Plastikon Issues Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension Due to Microbial Contamination

June 7, 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
NDC 0904-6846-73 0904-6840-72 0904-6838-73 0904-6839-73
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 sdixon@plastikon.com 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.

Source: FDA

 

Plastikon Healthcare Issues Voluntary Nationwide Recall of Certain Products Due to Microbial Contamination

March 24, 2022 - Lawrence, KS, 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.

Risk Statement: 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 in the table 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 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. The products are private labeled for Major Pharmaceuticals.

Product Name Milk of Magnesia 2400 mg/30 mL Oral Suspension Magnesium Hydroxide
1200mg/Aluminum
Hydroxide
1200mg/Simethicone
120mg per 30 mL
Acetaminophen 650mg/
20.3mL
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.
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.
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. 20024A/Mar 2022 20025A/Mar 2022
20041A/May 2022
20042A/May 2022 20043A/May 2022
20045A/May 2022
20046A/May 2022
20047A/May 2022
21067A/Jun 2023
20040A/May 2022
NDC 0904-6846-73 0904-6838-73 0904-6820-76
Type of 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)

 

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.

Consumers with questions regarding this recall can contact Plastikon by phone at 785-330-7109 or email address (sdixon@plastikon.com) Monday through Friday from 9 am to 4 pm CST. 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.

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.

Source: FDA