Summary Company Announcement Date: March 30, 2022 FDA Publish Date: March 30, 2022 Product Type: CosmeticsDrugs Deodorant Reason for Announcement: Recall Reason Description Elevated levels of benzene Company Name: Unilever Brand Name: Brand Name(s) Product Description: Product Description Aerosol Antiperspirants Company Announcement March 30, 2022 – Englewood Cliffs, New Jersey– Unilever United States is voluntarily…
Iodine-Containing Contrast Media: Drug Safety Communication – FDA Recommends Thyroid Monitoring in Babies and Young Children Who Receive Injections of Iodine-Containing Contrast Media for Medical Imaging
[Posted 03/30/2022] AUDIENCE: Pediatrics, Radiology, Health Professional, Patient, Caregiver, Pharmacy ISSUE: The FDA approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring recommendations for children 3 years or younger. The warning describes the risk of underactive thyroid or a temporary decrease in thyroid hormone levels. These…
Food Serving Sizes Have a Reality Check
Image Español The last time you scooped some ice cream for dessert, did you limit yourself to half a cup? If you took more—you’re right in step with most people these days. Likewise with a soft drink: Do you drink 8 ounces, 12 ounces, or even the whole 20-ounce bottle? Ice cream and soft drinks…
FDA D.I.S.C.O. Burst Edition: FDA approval of CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer therapeutic approval. On February 28, 2022, the FDA approved ciltacabtagene autoleucel (brand…
Teva Issues Voluntary Nationwide Recall of One Lot of IDArubicin Hydrochloride Injection USP 5 mg/5 mL Due to the Presence of Particulate Matter
Summary Company Announcement Date: March 29, 2022 FDA Publish Date: March 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Particulate Matter (silica and iron oxide) Company Name: Teva Pharmaceuticals Brand Name: Brand Name(s) Teva Pharmaceuticals Product Description: Product Description IDArubicin Hydrochloride Injection USP Company Announcement Teva Pharmaceuticals has initiated a voluntary…
Prefilled Saline Flush Syringe Conservation Strategies – Letter to Health Care Personnel
March 21, 2022 The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/ flush syringes. Prefilled 0.9% sodium chloride IV lock/ flush syringes are in shortage because of an increase in demand during the COVID-19 public health emergency,…
Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential Manufacturing Defect
Summary Company Announcement Date: March 21, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential clogging of the needle preventing the dispensing of epinephrine Company Name: Adamis Pharmaceuticals Corporation Brand Name: Brand Name(s) Adamis Pharmaceuticals Corporation Product Description: Product Description SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3…
Pfizer Voluntary Nationwide Recall of Lots of ACCURETICTM (Quinapril HCl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril HCl/Hydrochlorothiazide Tablets Due to N-Nitroso-Quinapril Content
Summary Company Announcement Date: March 22, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a nitrosamine, N-nitroso-quinapril Company Name: Pfizer Brand Name: Brand Name(s) Accuretic, Greenstone Brand Product Description: Product Description Accuretic™ (quinapril HCl/hydrochlorothiazide); quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tablets Company Announcement NEW YORK,…
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
Summary Company Announcement Date: March 24, 2022 FDA Publish Date: March 24, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial Contamination Company Name: Plastikon Healthcare, LLC Brand Name: Brand Name(s) Major Pharmaceuticals Product Description: Product Description Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and…
Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity
Summary Company Announcement Date: March 21, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a Nitrosamine Impurity Company Name: Sandoz, Inc. Brand Name: Brand Name(s) Product Description: Product Description Orphenadrine Citrate 100 mg Extended Release (ER) Tablets Company Announcement Princeton, NJ, Sandoz Inc. (“Sandoz”) is…