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Company Announcement Date: August 28, 2020 FDA Release Date: August 31, 2020 Product Category: Drug Recall Reason: Product Confusion (Siling bottles may be packaged in the wrong small box) Product Description: Injection methylacycline and hydrochloride Mylan said its MYlan Institutional LLC subsidiary in the United States is voluntarily recalling four batches of injectable products nationwide.
recall is at the hospital/clinic level and involves two products: Amiodarone HCl hydrochloride injections, USP 450 mg / 9 mL, 10 xylenic acid injections per box (Tranexamic Acid), USP 1000 mg / 10 mL, 10 xilin bottles per box Recall reason The reason for recalling these batches is that products labeled as amino acid injections may contain hydrochloride iodide silin bottles in their small boxes, while products labeled amine hydrochloride iodide may contain methylamine bottles in their small boxes.
Mylan said the information on the label was correct for a single Xilin bottle package for the product in the small box.
for both drugs, they can only be managed in hospitals by trained medical professionals.
, Mylan has not received any reports of adverse events related to this recall.
patients risk hydrochloride iodone injections and amino acid injections used to treat different diseases.
hydrochloride iodone injection is an anti-arrhythmic drug used to treat and prevent other treatments of frequently occurring cerium fibrillation (VF), hemodynamic instability of roomal tachyrostatic speed (VT).
in haemophiliac patients, short-term injections of methiciltic acid are recommended to reduce or prevent bleeding and to reduce the need for alternative therapies during and after tooth pullout.
if the drug is given to the patient instead of acetone, it may be a threat to patient safety (and vice versa).
Careless use of hydrochloride iodone injections can lead to lower blood pressure and irregular heart rhythms, including lower-than-expected heart rhythms, which can be life-threatening and affect heart function.
delayed use of hydrochloride iodone injections when needed can lead to persistent heart rhythms and can be life-threatening and affect heart function.
the use of amino acid injections can lead to adverse events, including blood clotting, seizures, hypersensitive reactions, visual impairment and dizziness.
recalls these batches were distributed to wholesalers and hospitals/clinical pharmacies nationwide across the United States between April 2020 and July 2020.
of the recall is as follows: Mylan is notifying its wholesalers and hospital/clinic pharmacies by letter and is arranging for the recalled product to be returned to the dealer, Stryccle.
should be discontinued/further distributed to wholesalers and hospital/clinic pharmacies involved in the recalled products.
who may have questions about the recall can contact Mylan Customer Relations Monday through Friday from 8 a.m. to 5 p.m. EST.
consumers should contact their doctor or medical provider if they experience any problems with the use of these medicines.
adverse reactions or quality issues encountered using this product can be reported to the FDA's MedWatch Adverse Event Reporting Program online, by regular mail or fax.
recall was made with the FDA's knowledge.
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