Summary Company Announcement Date: September 13, 2021 FDA Publish Date: September 13, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Exceeds Specification for Total Yeast and Mold Counts Company Name: Jacobus Pharmaceutical Company Inc. Brand Name: Brand Name(s) Product Description: Product Description Ruzurgi® (amifampridine) 10 mg tablets Company Announcement Plainsboro, New Jersey, Jacobus…
All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: ultrasound gel products and lotions manufactured by Eco-Med are marketed by a number of distributors, under different product names, which include but are not limited…
ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the Presence of Particulate Matter
Summary Company Announcement Date: September 03, 2021 FDA Publish Date: September 07, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of visible particulate matter Company Name: ICU Medical, Inc. Brand Name: Brand Name(s) Product Description: Product Description Aminosyn II, 15%, An Amino Acid Injection, Sulfite Company Announcement ICU Medical, Inc. is voluntarily…
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit
Summary Company Announcement Date: September 08, 2021 FDA Publish Date: September 08, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product kit may contain incorrect diluent. Company Name: Azurity Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Company Announcement Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test
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 have a quick update on another recent FDA cancer drug approval. On August 25, 2021, FDA approved ivosidenib (brand name Tibsovo)…
Janus Kinase (JAK) inhibitors: Drug Safety Communication – FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
AUDIENCE: Patient, Rheumatology, Gastroenterology, Cardiology, Neurology, Oncology, Pharmacy, Health Professional ISSUE: The FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib) to include information about the risks of serious heart-related events, cancer, blood clots, and death. Based on the review of a large randomized safety…
Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits
Summary Company Announcement Date: September 01, 2021 FDA Publish Date: September 02, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples Company Name: Meridian Bioscience, Inc. Brand Name: Brand Name(s) Meridian Bioscience, Inc. Product Description: Product Description LeadCare®…
Hearing Aids and Personal Sound Amplifiers: Know the Difference
You’ve likely seen them advertised on television—small electronic sound amplifiers that allow users to enjoy nighttime TV without disturbing sleepers, or to hear their toddlers from many yards away. While these personal sound amplifiers may help people hear things that are at low volume or at a distance, the Food and Drug Administration (FDA) wants…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced solid tumors, and Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinoma
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 two recent FDA cancer drug approvals. On August 17, 2021, the FDA approved dostarlimab-gxly (brand name…
Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency
Summary Company Announcement Date: August 27, 2021 FDA Publish Date: August 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potency Company Name: Teligent Pharma, Inc. Brand Name: Brand Name(s) Product Description: Product Description Lidocaine HCl Topical Solution 4% Company Announcement Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl…