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Reason for the recall, Fessen Yuskaby voluntarily recalled two batches of 0.9% of the right-hand metomic hydrochloric acid, with a specification of 200 mcg/50 mL (4 mcg/mL) and packaged in a 50 mL vial.
FessenYuskabi initiated the recall because of the presence of trace amounts of Lidocain in both batches.
FessenYuskabi said its investigation showed that the contamination problem was limited to both batches.
recall is being performed at the consumer level.
FessenYuskabi said so far no reports of adverse drug reactions to recall batches have been received.
, however, the use of hydrochloric acid, which contains trace amounts of lidocarin, may cause allergic reactions and may be life-threatening in patients with lidocain allergy.
0.9% sodium chloride injection at right metamine hydrochloride is approved for intravenous injection for sedation of non-intubation patients before and/or during surgery and other surgery.
RecallS The following two recalled products were distributed nationwide between June 3, 2019 and April 8, 2020 to wholesalers, distributors, hospitals, and pharmacies nationwide: Figure: Form Header: Product Name/Spec, NDC Number, Product Code, Lot Number, Expiration Date, First Shipment Date and Last Shipment FessenYuskabi Notified their distributors and customers by letter, and asked customers and distributors to immediately inspect and suspend the use of any affected products.
distributors should notify their customers and instruct them to quarantine and stop distributing any affected batches and return the product to Fessenyuskabi.
recall letters and response forms are available on The Eisenjusskaby website.
adverse reactions or quality issues encountered with the product can be reported to the FDA's MedWatch Adverse Event Reporting Program by online, regular mail, or fax.
the recall was made with the knowledge of the FDA.
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