Country Fresh Orlando, LLC. of Orlando, Florida, is recalling 5,999 cases of diced bell pepper, vegetable kabobs, and creole and fajita mixed diced vegetables (product descriptions attached), because they have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which 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.
Wakefern Food Corp. Voluntarily Recalls ShopRite Semi-Sweet Real Chocolate Chips
Wakefern Food Corp. has initiated a voluntary recall of its ShopRite brand Semi-Sweet Real Chocolate Chips. The chips were sold in 24 oz. bags bearing a UPC bar code of 041190 02668 and Best if Used By dates of April 11, 2019 and April 12, 2019.
PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all unexpired lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose Due to Sub-Potency
PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered.
FDA clears mammography device with option for patient-assisted compression
Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.
FDA approves Mylotarg for treatment of acute myeloid leukemia
The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).
Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection, USP, CII, (2 mg/mL) 1mg/mL Vial, and Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial, Due to a Lack of Sterility Assurance
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
Hospira Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial Due to The Presence of Particulate Matter Within a Single Vial
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial.
Mid Valley Pharmaceutical LLC Issues Voluntary Recall of Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup Due to Potential Contamination with Burkholderia Cepacia.
Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall.
Lucky Mart Inc. Issues Voluntary Nationwide Recall Of Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient
Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling.