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Aurobindo Pharma's arm recalls 2 antibiotic injections from US

Press Trust of India  |  Hyderabad 

AuroMedics Pharma LLC, a US subsidiary of Ltd,has initiated voluntary recall of two lots each of two from the US market followingcustomer complaintsabout presence of particles in the vial.

The fresh recall follows a recent withdrawal of over 1.5 million by the company due to "Lack of Assurance of "

According to a letter issued to the US Food and Drug Administration department, the recall and Sulbactam for injection, USP, Single-Dose vial, to the hospital has been initiated due to customer complaints of the presence of red particulate matter in the product.

The recall and for injection, USP 3.375 g (Piperacillin Sodium equivalent to of Piperacillin USP and Sodium equivalent to 0.375 g of USP).

Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital levelhas been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial.

"is notifying its distributors and customers by recall and is arranging for replacement etc. of all recalled product."

Consumers, distributors retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase, contact their doctor as appropriate," Auromedics said in the letter on both the recalls.

Ampicillin and SulbactamandPiperacillin and Tazobactam are used to treat of different natures at different situations.

Auromedics did not mention the quantities of both the products which are being recalled.

"To date, has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots,"the drug maker said.

All the injections were manufacturedby Limited at its plant in India, for AuroMedics Pharma, to be distributed in the US.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Sun, May 13 2018. 12:50 IST