Monthly Archives: March 2022

USA – Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL, Unit Dose Cups, Due to Microbial Contamination

FDA

Summary

Company Announcement Date: 
FDA Publish Date: 
Product Type: Drugs
Reason for Announcement:
Microbial Contamination
Company Name: Plastikon Healthcare, LLC
Brand Name: Major Pharmaceuticals
Product Description: Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL

Company Announcement

3/24/2022 – 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.


Company Contact Information

Consumers:
Plastikon, Sandy Dixon
 785-330-7109
 sdixon@plastikon.com

Product Photos

Belgium – SHELLED PISTACHIOS, ITALIAN MIX and MIXED NUTS WITH DRIED OLIVES- Aflatoxin

AFSCA

Recall from Delhaize
Product: SHELLED PISTACHIOS, ITALIAN MIX and MIXED NUTS WITH DRIED OLIVES.
Problem: too high aflatoxin content.


Delhaize asks its customers not to consume and to bring the products below back to the store.

In collaboration with the FASFC, Delhaize has decided to withdraw these products from the market and to recall them from consumers due to too high aflatoxin content.

Product information:

Name: SHELLED PISTACHIOS
Brand: Delhaize
EAN code: 5400112508633 Best
before: all dates between 06/21/2022 and 09/11/2022

Name: ITALIAN MIX
Brand: Delhaize
EAN code: 5400112326770 Best
before: all dates between 06/16/2022 and 08/27/2022

Name: MIXED NUTS WITH DRIED OLIVES
Brand: Delhaize
EAN code: 5400113689720 Best
before: all dates between 06/12/2022 and 08/18/2022

Marketing period: from 29/12/2021 to 25/03/2022

Every day, Delhaize carries out hundreds of internal quality controls in order to guarantee the quality and food safety of its products at all times.

In the meantime, Delhaize has already taken all affected products off the shelves and tightened checks on products and suppliers. Customers who have purchased these products are asked not to consume them. Customers have the option of returning the products in question to the point of sale where they purchased them. Reimbursement for each affected item is guaranteed.

Other products of the same assortment are not affected and can therefore be consumed in complete safety. Delhaize would like to apologize for the inconvenience caused.

For further information , customers can contact our Customer Service on the free number 0800/95 713.

Denmark – Marzipan – Mold/Mould

DVFA

Pure Raw Marzipan

Coop Danmark A / S is recalling a batch of Coop pure raw marzipan due to the discovery of mold in the product.

Recalled Foods , Published: March 25, 2022

Which food:
Coop pure raw marzipan
Net weight: 200g
Best before date: 08.09.2022
EAN barcode number: 7340191111134

Sold in:
Kvickly, SuperBrugsen, Fakta, Coop 365 and Dagli’Brugsen throughout the country and at Coop.dk/mad

Virksomhed , which recalls:
Coop Danmark A / S, Roskildevej 65, 2620 Albertslund

Cause:
The company has established that there is a risk of mold in the product.

Risk:
Mold formation makes the product unsuitable as food.

Advice for consumers:
The Danish Veterinary and Food Administration advises consumers to deliver the product back to the store where it was purchased or to discard it.

USA – Public Health Alerts Residents of Possible Exposure to Hepatitis A at Sunlife Organics Juice Bar in West Hollywood California

Food Poison Journal

The Los Angeles County Department of Public Health (Public Health) is working with Sunlife Organics Juice Bar in West Hollywood to alert consumers of a possible hepatitis A exposure. 
The Los Angeles County Department of Public Health identified hepatitis A virus infection in a food handler who worked at this location.

No additional cases have been identified at this time.

Public Health recommends hepatitis A vaccination for patrons who consumed food or beverages from Sunlife Organics in West Hollywood between March 14–17, 2022. Vaccination is not necessary for people who previously completed the hepatitis A vaccine series or are known to have a past infection. To prevent infection or reduce illness, hepatitis A vaccine should be administered within 14 days after a known exposure.

Hepatitis A vaccinations might be available through local pharmacies or physicians’ offices. In addition, Public Health will be offering free hepatitis A vaccinations to exposed persons at:

Hollywood Wilshire Health Center 
5205 Melrose Ave. 
Los Angeles, CA 90038

· Sunday, March 27, 2022 from 10am-1pm

· Monday, March 28, 2022 from 10am – 1pm

· Tuesday, March 29, 2022 from 8am – 4pm

Most people will have protective levels of antibody after one dose of the Hepatitis A vaccine but can choose to visit their primary care provider to complete the series with a second dose 6 months after receiving their first dose.

Hepatitis A is a liver infection caused by the hepatitis A virus. Hepatitis A causes acute liver disease, which may be severe. Hepatitis A is highly contagious and can be spread from person-to-person through the fecal-oral route (when contaminated feces from an infected person are somehow ingested by another person during close personal contact) or by eating or drinking contaminated food or water). Most adults with acute hepatitis A will have symptoms that may include fever, fatigue, nausea, vomiting, abdominal pain, dark colored urine and jaundice (yellowing of the skin or eyes). There is no specific antiviral treatment.

Vaccination is the best way to prevent disease. In addition, infection can be prevented by vaccination within 14 days after a known exposure to a person with infectious hepatitis A. Older adults and people with weakened immune systems might benefit from receiving immune globulin (IG) in addition to hepatitis A vaccination for prevention after an exposure. For any questions about hepatitis A or the need for immune globulin, Public Health recommends that you speak to your primary care provider. If you do not have a regular provider, call 2-1-1 for assistance.

Public Health will continue monitoring all known individuals who may have been exposed to individuals ill with hepatitis A

Germany – “Alburj – Halva with extra pistachios” 800 g Production date 07.02.2021 – Salmonella

LMW

Alert type: Food
Date of first publication: 03/25/2022
Product name:

“Alburj – Halva with extra pistachios” 800 g Production date 07.02.2021

Manufacturer (distributor): Distributor: Kosebate GmbH
Reason for warning:

Salmonella was detected in a sample.

Packaging Unit: 800g
Production date: 07.02.2021
Further information:

Reference is made to the company’s attached customer information.

Click to access Aushang+R%FCckruf+Halva+mit+extra+Pistazien+800g.pdf

Germany – * Baby food * Similac, Alimentum and EleCare from the ABBOTT brand

LMW

Alert type: Food
Date of first publication: 03/25/2022
Product name:

* Baby food * Similac, Alimentum and EleCare from the ABBOTT brand

Product images:

image.jpg

BVL

Manufacturer (distributor): Abbott Nutrition in Sturgis, Michigan Country of origin: United States of America
Reason for warning:

Possible contamination with Salmonella Newport and Cronobacter sakazakii

Packaging Unit: 400 grams
Durability: from April 01, 2022
Lot identification: The first two digits of the lot number start with 22 to 37 AND the lot numbers contain the details K8, SH or Z2.
Further information:

Reference to a public warning from the US Food and Drug Administration:

Possible contamination of US infant formula with Cronobacter sakazakii and Salmonella Newport

Status 03/24/2022

The US Food and Drug Administration (FDA) warns against the use of certain powdered infant formulas manufactured by Abbott Nutrition in Sturgis, Michigan.

On February 17, 2022, Abbott announced that it had initiated a voluntary recall of certain lots of potentially affected products. The products in question are Similac, Alimentum and EleCare powdered food, which are manufactured at the plant in Sturgis, Michigan.

The recall is related to consumer complaints about Cronobacter sakazakii and Salmonella Newport infections in the United States. In all of these cases, infant formula from the manufacturer Abbott Nutrition is said to have been consumed. All five cases related to these ailments required hospitalization. In two cases, the infection may have contributed to the deaths of the patients.

The FDA is warning against the purchase and consumption of certain infant formulas manufactured at Abbott Nutrition’s Sturgis, Michigan facility.

The products were shipped within the USA and in member states of the EU (Italy, Ireland, Croatia, Netherlands, Slovenia, Spain) and other third countries (e.g. Great Britain, India, Islamic Republic of Iran, Northern Ireland, Russian Federation, Turkey, Ukraine, United States of America ) expelled. According to current knowledge, the products mentioned were not sold in Germany.

There is a possibility that consumers could have purchased the products online via marketplaces or through short-term stays in the Member States or third countries.

The FDA advises consumers not to use Similac, Alimentum, or EleCare powdered infant formula if:

  • the first two digits of the batch number begin with 22 to 37 and
  • the details K8, SH or Z2 are included and
  • a best-before date of April 1, 2022 is specified

The manufacturer offers the possibility to check the batch number of purchased products on the following page:  https://www.similacrecall.com/us/en/product-lookup.html

For more information on the FDA’s warning, please visit the following link: https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced- Abbott Nutrition Facility

The manufacturer’s recall can be found at the following link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant

For the warning in Turkish language, please refer to the following link: https://www.titck.gov.tr/duyuru/ilac-geri-cekme-24022022101035

Information on Salmonella and Cronobacter sakazakii

Salmonella  and  Cronobacter sakazakii  can cause illness in infants when present in powdered infant formula. Although Cronobacter sakazakii and Salmonella cannot grow in powdered infant formula, they can survive for a long period of time and therefore pose a potential risk after liquid addition if the product is not heated sufficiently during preparation. Contamination of infant formula powder with Cronobacter sakazakiiand salmonella can cause serious illnesses in infants, such as diarrhea (sometimes bloody), fever, sepsis or meningitis, which can cause serious neurological and developmental problems and, in rare cases, can be fatal. Sepsis and meningitis can present with poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), and abnormal breathing and movements. Among infants, newborns (<28 days), especially preterm, low birth weight, or immunocompromised infants are most at risk of becoming infected.

(Unofficial translation of the information at: https://www.fsai.ie/news_centre/food_alerts/Similac.html )

Further information on salmonella, also in other languages, can be found here: http://www.infectionsschutz.de/erregersteckbriefe/salmonellen

Germany – Kerem – mini figs – 250g – Ochratoxin A

LMW

Photo Figs.JPG

Alert type: Food
Date of first publication: 03/25/2022
Product name:

Kerem – mini figs – 250g

Product images:

Manufacturer (distributor): Fresh Nuts GmbH, Pinkertweg 10, 22113 Hamburg
Reason for warning:

Exceeding the limit value of the active substance ochratoxin A

Packaging Unit: 250 g
Durability: at least April 30, 2022
Lot identification: 21002960 / 21003123 / 21003122 / 22000191
Manufacturer’s website:

France – Fig heart goat cheese balls 90g – Listeria monocytogenes

Gov france

Identification information of the recalled product

  • Product category Food
  • Product subcategory Milk and dairy products
  • Product brand name FROMAOCEUR
  • Model names or references Fig heart goat cheese balls 90g
  • Identification of products
    GTIN Lot Dated
    3760064261461 22-042 Use-by date 03/22/2022
    3760064261461 D22-042 Use-by date 03/23/2022
    3760064261461 S22-063 Use-by date 04/12/2022
    3760064261461 S22-080 Use-by date 04/29/2022
  • Marketing start/end date From 02/17/2022 to 03/25/2022
  • Storage temperature Product to be stored in the refrigerator
  • Health markFR-16.292.066-CE
  • Geographic area of ​​sale Whole France
  • Distributors CASINO, VIVAL, SPAR and Casino CARREFOUR AUCHAN distribution networks

Practical information regarding the recall

  • Reason for recall Potential presence of listeria monocytogenes
  • Risks incurred by the consumer Listeria monocytogenes (causative agent of listeriosis)

Canada – Certain Taylor Shellfish Canada ULC brand Oysters recalled due to Norovirus

CFIA

Summary

Product
Certain oysters
Issue
Food – Microbial Contamination – Norovirus
What to do

Do not consume, use, sell, serve, or distribute the recalled products

Canada – Jimel’s Bakery brand baked goods recalled due to possible Salmonella contamination from rodent infestation

CFIA

Summary

Product
Various baked goods
Issue
Food – Microbial Contamination – Salmonella
What to do

Do not consume the recalled products

Affected products

Issue

Jimel’s Bakery and Food Products is recalling Jimel’s Bakery brand baked goods from the marketplace due to possible Salmonella contamination from rodent infestation.

The recalled products have been sold in Manitoba.

What you should do

  • If you think you became sick from consuming a recalled product, call your doctor
  • Check to see if you have the recalled products in your home
  • Do not consume the recalled products
  • Recalled products should be thrown out or returned to the location where they were purchased

Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.