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On August 31st the FDA's official website announced that Mylan Pharmaceuticals, based in the United States, was voluntarily recalling four batches of injections nationwide, involving two products.
recall is due to confusion between the two injectable Xilin bottles in a small box package.
said it had not received any reports of adverse events related to the recall so far.
Company Announcement Date: August 28, 2020 FDA Release Date: August 31, 2020 Product Category: Drug Recall Reason: Product Confusion (Sillin bottles may be packaged in the wrong small box) Product Description: Injection methylacycline and hydrochloride iodide Mylan said its MYlan Institutional LLC subsidiary in the United States is voluntarily recalling four batches of injection products nationwide.
This recall is at the hospital/clinic level and involves two products, namely: the reason for the recall of these batches is that the product labeled as acetic acid injections may contain a bottle of hydrochloride iodide in its small box, and a product labeled hydrochloride iodide may contain a bottle of methyl acrylic acid in its small box.
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 with risk of hydrochloride iodide injections and amino acid injections are used to treat different diseases.
hydrochloride iodone injection is an anti-arrhythroid drug used to treat and prevent other treatments of frequently occurring atrial fibrillation (VF), hemodynamic instability of roomal tachyrostatic (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 immediately endanger life and affect heart function.
delayed use of hydrochloride 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 are 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.
if consumers encounter any problems with the use of these drugs, they should contact their doctor or medical provider.
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 by fax.
recall was made with the FDA's knowledge.