Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Ibuprofen Lysine Injection, Due to Particulate MatterLenoir, NC. Exela Pharma Sciences, LLC (“Exela”), in association with marketer X-Gen Pharmaceuticals, Inc. (“X-Gen”), is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. Some of the vials have been found to contain particulate matter.
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. Neither Exela nor X-Gen has received any reports of adverse events related to this recall. More information
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Kingsway Trading Inc. Recalls “Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement” because it Contains Banned Ephedra Alkaloids
Kingsway Trading Inc. of Brooklyn, NY is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium & Siler Combo (Bi Yan Pian)” Batch No. 130401 & Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item.
Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that may result from the use of these products under their labeled conditions of use, or under ordinary conditions of use if the labeling is silent. More information
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FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate
Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, we are requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels. Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the possibility of serious allergic reactions in their labels. More information
U.S. Smokeless Tobacco Company Voluntarily Recalls Certain Smokeless Tobacco Products Manufactured at its Franklin Park, IL Facility
U.S. Smokeless Tobacco Company (USSTC) is voluntarily recalling certain of its smokeless tobacco products, manufactured at USSTC’s facility in Franklin Park, IL. USSTC has notified the FDA of the recall and is working with federal authorities on this matter.
USSTC initiated the recall after receiving eight consumer complaints of foreign metal objects, including sharp metal objects, found in select cans. In each case, the object was visible to the consumer and there have been no reports of consumer injury. More information
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FDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV
The class labeling applies to the following HCV direct acting antiviral (DAA) agents:
The class labeling applies to the following HCV direct acting antiviral (DAA) agents:
- Daklinza (daclatasvir)
- Epclusa (sofosbuvir/velpatasvir)
- Harvoni (ledipasvir/sofosbuvir)
- Olysio (simeprevir)
- Sovaldi (sofosbuvir)
- Technivie (ombitasvir/paritaprevir/
ritonavir) - Viekira Pak (ombitasvir/paritaprevir/
ritonavir tablets; dasabuvir tablets) - Viekira XR (dasabuvir/ombitasvir/
paritaprevir/ritonavir) - Zepatier (elbasvir/grazoprevir)
More information
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información importante sobre seguridad de los medicamentos en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en inglés y la de español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA |
FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients. More information
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Drug Shortages Reported to be Resolved by Manufacturers During the Past 2 Weeks:
- Epinephrine Injection, 1 mg/mL
- Fomepizole Injection
- Ceftazidime and Avibactam (AVYCAZ) for Injection, 2.5g
Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks:
Information about blood and biologic shortages, resolved shortages, and discontinuations
La FDA reconoce las consecuencias significativas para la salud pública que pueden resultar de la escasez de medicamentos y hace un gran esfuerzo dentro de sus facultades legales para abordar yprevenir la escasez de medicamentos. La escasez se produce por muchas razones, incluyendo problemas de fabricación y calidad, retrasos y discontinuación del producto. Cuando los problemas son descubiertos por la empresa o el público y reportados a la FDA o se descubren por inspecciones de la FDA, la FDA trabaja en estrecha colaboración con la empresa para hacer frente a los riesgosinvolucrados y evitar daños a los pacientes. La FDA también considera el impacto que una escaseztendría en la atención médica del paciente y al acceso del producto y trabaja con la empresa pararestablecer el suministro al tiempo que garantiza la seguridad de los pacientes. Más información
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