- Shoppers-Plaza Issues Voluntary Nationwide Recall of Fouzee Sugarlin Herbal Formula Due To Presence Of Undeclared Metformin And Glyburide
Audience: Consumer December 16, 2024 – Los Angeles, California - Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. See below for photo of product labeling. Fouzee Sugarlin Herbal...
- FDA Adds Boxed Warning to Veozah (fezolinetant) to Highlight the Known Risk of Rare But Serious Liver Injury
Audience: Patient, Health Professional, OBGYN, Endocrinology Update: December 16, 2024FDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury associated with use of menopause medicine Veozah...
- Drug Safety Communication: Ocaliva (obeticholic acid) - Serious Liver Injury Being Observed in Patients without Cirrhosis
Audience: Gastroenterology, Hepatology, Patient, Health Care Professional, Pharmacy ISSUE: The FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did...
- Buy-herbal.com Issues Voluntary Nationwide Recall of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules Due to Undeclared Furosemide, Dexamethasone and Chlorpheniramine
Audience: Consumer Flushing, New York, Buy-herbal.com is voluntarily recalling all lots within expiry of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules to the consumer level. FDA analysis has found these products to contain undeclared Furosemide...
- FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel)
Audience: Health Professional November 27, 2024 -- Since approval, the Food and Drug Administration (FDA) has received additional reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome and acute myeloid...
- Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole
Audience: Healthcare Provider, Pharmacy, Consumer November 20, 2024 -- MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. FDA...
- Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling
Audience: Healthcare Provider, Pharmacy, Consumer November 19, 2024 -- Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of...
- VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Audience: Consumers November 4, 2024 – Sacramento, CA, VitalityVita.com is voluntarily recalling lot 230811, Exp 8/11/25, of VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level...
- Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Audience: Consumers November 4, 2024 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The...
- FDA Warns Patients and Health Care Professionals Not to Use Compounded Drugs from Fullerton Wellness
Audience: Patients, Health Care Professionals November 1, 2024 -- FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical...
- Do Not Purchase or Use Skin-Cap Aerosol Spray Products Because They May Be Harmful to Your Health
Audience: Consumers October 30, 2024 -- FDA is warning consumers to not purchase or use Skin-Cap aerosol spray products because they may contain undisclosed steroids. This product, sold by Chemigroup France, formerly known as Cheminova...
- Public Safety Notification on Amniotic Fluid Eyedrops
Audience: Patients, Health Care Practitioners October 17, 2024 Update: In August 2024, FDA received information from two consumers who reported adverse events such as shooting pain in the eyes after using Regener-Eyes, an ophthalmic drug product...
- C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients
Audience: Consumers October 16, 2024 – National City, CA, C&A Naturistics is voluntarily recalling all lots of AK Forte, 400 mg tablets, to the consumer level. FDA analysis has found the product to be tainted Diclofenac, Dexamethasone, and...
- Staska Pharmaceuticals, Inc. Issues Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles
Audience: Healthcare Provider, Pharmacy October 16, 2024 -- Bennet, NE -- STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This...
- FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
Audience: Industry October 2, 2024 -- The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022...
- FDA is Alerting Patients and Health Care Professionals About the Voluntary Withdrawal of Oxbryta from the Market Due to Safety Concerns
Audience: Health Care Professionals, Patients September 26, 2024 -- FDA is alerting patients, caregivers, and health care professionals that Oxbryta (voxelotor) is being voluntarily withdrawn from the market by the manufacturer due to safety...
- Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle
Audience: Healthcare Provider, Pharmacy Foster City, Calif., September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury (remdesivir) for Injection 100 mg/vial, to the consumer...
- Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination
Audience: Healthcare Provider, Pharmacy, Consumer September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was...
- Drug Safety Communication: FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause
Audience: Patient, Health Professional, OBGYN, Endocrinology September 12, 2024 -- The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and...
- FDA Warns Consumers Not to Purchase or Use Umary and Amazy Products As They May Be Harmful To Your Health
Audience: Consumers September 5, 2024 -- FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your health. This is due to potentially dangerous hidden drug ingredients...
- Veata LLC Issues Voluntary Nationwide Recall of Endurance Pro Capsules Due to the Potential Presence of Undeclared Sildenafil
Audience: Consumers August 14, 2024 – Sacramento CA, Veata LLC is voluntarily recalling lot 230811, Exp 8/11/25 of Endurance Pro Energy Boost capsules, packaged in 10-count blisters in a cardboard carton to the consumer level. Veata LLC was...
- Boulla LLC Issues Voluntary Nationwide Recall of Boom Max Capsules Due to the Potential Presence of Undeclared Sildenafil
Audience: Consumers August 14, 2024 – Sacramento CA, Boulla LLC is voluntarily recalling lot number 230811, exp 8/11/25 of Boom Max capsules packaged in 10-count blisters packaged in a carton to the consumer level. Boulla LLC was notified by...
- B. Braun Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers Due to the Potential for Particulate Matter and Leakage
Audience: Healthcare Provider, Pharmacy, Consumer BETHLEHEM, PA - August 8, 2024 – B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers within the United...
- FDA Warns Consumers to Not Purchase or Use Unapproved Inhalant Products Marketed for Alertness and Energy Boosting
Audience: Consumer August 6, 2024 -- FDA is warning consumers to not purchase or use certain inhalants, which are unapproved drugs marketed to promote alertness and boost energy. These products primarily contain ammonia. Inhaling ammonia can...
- Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels
Audience: Healthcare Provider, Pharmacy, Consumer DEERFIELD, Ill., AUG. 5, 2024 – Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the...