Recalls That Should Be on Your Radar—Week of Septmber 8, 2019

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Plastikon Healthcare Issues Recall for Specific Milk of Magnesia Products due to Microbial Contamination

Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling Milk of Magnesia 2400 mg/30 mL Oral Suspension, lots 19027D and 19027E, to the patient level. Plastikon Healthcare initiated this recall because these product lots did not meet Plastikon’s in-house microbiological specification for Total Aerobic Microbial Count.

This product is packaged for institutional use and is sold to clinics and hospitals, the patient population most likely to use the product are likely immunocompromised. 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 has not received any customer complaints or reports of adverse events related to this issue. 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.

Milk of Magnesia 2400 mg/ 30 mL Oral Suspension is privately labeled by Major Pharmaceuticals® and packaged in cartons as indicated below. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler), who may have shipped to clinics, hospitals and healthcare providers, in the United States, in August 2019.

Read the full recall statement.

House of Spices (India) Issues Recall of MDH Sambar Masala Due to Salmonella Contamination

House of Spices (India) is recalling different lots of “MDH SAMBAR MASALA”, 3.5oz (100g) UPC code 6291103750327. This product is produced by R-PURE AGRO SPECIALITIES and distributed by HOUSE OF SPICES (INDIA). This product was tested by FDA through a certified laboratory to be positive for Salmonella.

Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. The most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating the contaminated product. The illness usually lasts 4 to 7 days. Most people recover without treatment. In some persons, however, the diarrhea may be so severe that the patient needs to be hospitalized. Older adults, infants, and persons with weakened immune systems are more likely to develop a severe illness. Individuals concerned about an illness should contact their health care provider.

Read the full recall statement.

Conagra Brands Issues Recall for Udi’s Hamburger Buns due to Potential for Foreign Matter Contamination

Conagra Brands is voluntarily recalling a limited quantity (approx. 2,200 cases) of Udi’s Classic Hamburger Buns due to the potential presence of small pieces of white plastic. The company discovered the issue which occurred when a dough scraper was inadvertently incorporated into the production process for a small amount of the product.

The product covered by this recall was distributed for retail sale in the U.S. The specific product information is listed below. No other Udi’s or Conagra Brands products are impacted by this recall.

Read the full recall statement.

Hospira, Inc. Issues Recall for 1 Lot of Bacteriostatic Water Due to Sterility Concerns

Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot.

In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events such as invasive bacterial infection, including bacterial meningitis, septicemia, and limited adverse events such as fever, chills, malaise, and cutaneous abscess may occur. To date, Hospira has not received reports of any such adverse events associated with this issue for this lot.

BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Read the full recall statement.

The Metrix Company Issues Recall for IV Flexible Containers Due to Potential Leak

The Metrix Company of Dubuque, Iowa is recalling specific lots of the empty IV flexible containers (bag) marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names, due to the potential for leaking of the IV bag at the chamber divider rod, which could result in a serious infection to the patient.

These bags are used for use in an intravenous admixture program, to store and deliver intravenous parenteral admixtures to patients. The empty bag is filled with parental admixtures by a healthcare provider (e.g. licensed pharmacist) under normal pharmacy conditions, e.g. laminar flow hood.

Read the full recall statement.

Alfa International Seafood, Inc., Issues Recall for Yellow Fin Tuna

On September 6, 2019, Alfa International Seafood, Inc. of Medley, FL, voluntarily initiated a recall of refrigerated, wild-caught yellowfin tuna loins because of potentially elevated levels of histamine.

The tuna loins were sold at Baker’s, Dillon’s, Gerbes, JayC Food, Kroger and Payless stores in Alabama, Arkansas, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, Mississippi, Nebraska, Ohio, South Carolina, Tennessee, Virginia and West Virginia.

The tuna loins were labeled as either Yellowfin Tuna Steaks or Seasoned Yellowfin Tuna Steaks and were sold from either the service counter or tray-packed in a display case. The tuna loins were sold from August 20, 2019 through September 7, 2019 and had sell by dates between August 29, 2019 and September 14, 2019.

There have been five reported illnesses by consumers. While the company feels these were isolated incidents, it has initiated this voluntary recall to take to take every precautionary measure when it comes to customers’ health and safety.

Elevated levels of histamine can produce an allergic reaction called histamine or scombroid fish poisoning that may result in symptoms that generally appear within minutes to several hours after eating the affected fish.

Read the full recall report.