FDA Recalls Week of December 31, 2017

Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial

AuroMedics Pharma is voluntarily recalling one lot of Ampicillin and Sulbactam for Injection USP, 1.5 g in a Single-Dose vial (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt), to the hospital level. Lot AFO l 17001-A, Expiry date Dec 2018 has been found to contain glass particles. The affected Ampicillin and Sulbactam for Injection lot is packaged in a carton containing 10 vials, NDC: 55150-116-20. The product can be identified as a ‘clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc'. AuroMedics shipped the entire lot to wholesalers and/or hospitals nationwide on February 9, 2017.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.

You can read the Official FDA Recall Notification here.

Evershing International Trading Company Recalls Frozen Shredded Coconut Because of Possible Health Risk

Evershing International Trading Company is recalling 16 ounces Coconut Tree Brand Frozen Shredded Coconut because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. No illnesses have been reported to date.

Check out the Official FDA Recall Notification here.

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Linezolid Injection 600mg/300ml, due to Presence White Particulate Matter that has been Identified as Mold

AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag from one batch CLZ160007 was found to contain white particulate matter.

Use of a non-sterile injectable product could result in fatal infections in a broad array of patients. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.

Read the Official FDA Recall Notification, here.

Outbreaks of STEC O157:H7 Infections Spring Up in the US & Canada

The Centers for Disease Control and Prevention (CDC) have just announced that they are investigating a multistate outbreak of Shiga toxin-producing Escherichia coli (STEC) O157:H7 infections, the most commonly identified STEC in North America. A STEC O157:H7 outbreak has also sprung up in Canada, and has been linked back to contaminated romaine lettuce.

Read Contagion®’s coverage here.

Fresh Pak Inc. Recalls Lot Specific Sliced Apple Products Because of Possible Health Risk

Fresh Pak Inc. of Detroit, MI is announcing a voluntary Lot specific recall of red/green apple slices. Jack Brown Produce, Inc. (supplier) requested Fresh Pak Inc. to perform a recall for the reason that they could have potentially been contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short‐term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. To date, no illnesses have been reported in connection with this problem.

You can read the Official FDA Recall Notification, here.

Nodine's Smokehouse Inc. is Recalling Smoked Salmon 1.5 lbs, 8 oz Packages Due to Possible Listeria Monocytogenes Contamination

Nodine's Smokehouse, Inc. of Torrington, Connecticut is recalling Smoked Salmon 1.5 lbs, 8 oz packages. Lot numbers 40173 and 33173 because they have the potential to be contaminated with Listeria monocytogenes. Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, with high fever, severe headache, neck stiffness, and nausea as its primary symptoms. In rare cases, listeriosis is fatal; it can also cause miscarriages and stillbirths. People experiencing these problems should seek immediate medical attention. Pregnant women the very young, elderly, and persons with compromised immune systems are the most susceptible. The Smoked Salmon was distributed nationwide in retail stores and through mail orders. The product comes in 1.5 lb and 8 oz packages with lot numbers 40173 and 33173. No illnesses have been reported to date in connection with this problem.

Check out the Official FDA Recall Notification here.