Firm recalls IV for heart ailments

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Monday, July 14, 2014


SEVERAL batches of Dobutamine (as Hydrochloride) 12.5 mg/mL (250 mg/20mL) Solution for Injection (Dobulon) are now being recalled by its local distributor, I.E. Medica Inc.

According to the Food and Drug Administration (FDA), a voluntary recall has been made by the Mandaluyong-based company covering Batch Numbers DBI1301BC, DBI1302BC AND DBI1303BC (DRP-3997) changes in their appearances were noticed.

"I.E. Medica. is initiating a product recall of the specific batches due to change in appearance of the product from clear pale yellowish solution to dark yellow solution," said the FDA Advisory No. 2014-055.

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Dobutamine (as Hydrochloride) 12.5 mg/mL (250 mg/20mL) Solution for Injection (Dobulon) is used to increase the contractility of the heart in acute heart failure, as occurs in cardiogenic shock and myocardial infarction, and is also used in septic shock.

The product is packed in a box containing one vial Dobutamine (as Hydrochloride) 12.5 mg/mL, and each vial contains 20mL solution.

It is being manufactured by Celon Laboratories Limited, which is based in Reddy District, Andhra Pradesh, India.

The FDA said distributor, retailers, hospitals, pharmacies, or clinics that have the said batches are already instructed to discontinue further distribution, sale, and use.

Also, all field Food and Drug Regulation Officers have been directed to monitor the availability of the said product batches in the market. (HDT/Sunnex)

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