Food and Drug Administration--Recalls/Safety Alerts
Recall Information from FDA
06/16/2018 07:44 AM
Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk
Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") announced today, the voluntary recall of a limited quantity of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to select retailers in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin. Del Monte was notified by state agencies of the outbreak and its potential involvement.
06/13/2018 04:46 PM
World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens
World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Spicy Edamame 7oz, because it contains the undeclared shellfish/crustacean allergen “Oyster Extract” ingredient within the spicy sauce packet. People who have an allergy or severe sensitivity to shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.
06/04/2018 11:36 AM
Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter
Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.
06/01/2018 09:53 PM
Sanders Issues Allergy Alert on Undeclared Almonds in Fudge Mini Bites
Sanders announced today that it is recalling its 3.75oz Milk Chocolate Covered Fudge Mini Bites because they may contain undeclared almonds. People who have allergies to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.
06/01/2018 03:21 PM
SDQ Trading Inc Issues Alert on Undeclared Milk Allergen in Cheese Biscuits
SDQ Trading Inc. of 651A Lexington Ave, Brooklyn, NY 11221 is recalling its 16.5 oz packages of Cheese Biscuits because they may contain undeclared milk allergen. Consumers who are allergic to milk allergen may run the risk of serious or life-threatening allergic reactions if they consume this product.
06/01/2018 09:11 AM
SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags
On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were distributed between February 1, 2018 to May 13, 2018. The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use. If this takes place, the resuscitator bags may not deliver air to the patient and result in a delay in treatment and life-threatening health consequences. There have been no reported injuries to date.
05/31/2018 01:48 PM
Abbott Implements Corrective Action for Heartmate 3 Heart Pump
Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.
05/29/2018 10:23 AM
Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules
Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
05/29/2018 09:47 AM
Pious Lion Voluntary Recall Due to Possible Health Risk
Pious Lion located in Asheville, NC is voluntarily recalling two of their Kratom products: Pious
Lion Pure Premium Potent Limited Release Pink Bali, 1 oz and Pious Lion Pure Premium Potent
White Maeng DA, Bright Uplifting Energy, 4 oz due to the presence of Salmonella . Salmonella
is an organism which can cause serious and sometimes fatal infections in young children, frail or
elderly people, and others with weakened immune systems. Healthy persons infected with
Salmonella often experience fever, diarrhea, 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.
05/25/2018 05:48 PM
Giant/Martin’s Voluntarily Recalls Private Brand Frozen Broccoli Cuts
GIANT Food Stores, LLC is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution following a supplier notification that the product may have Listeria monocytogenes.