Hyderabad: AuroMedics Pharma LLC, a US subsidiary of Aurobindo Pharma Ltd, has initiated voluntary recall of two lots each of two injections from the US market following customer complaints about presence of particles in the vial.
The fresh recall follows a recent withdrawal of over 1.5 million injections by the company due to “Lack of Assurance of Sterility.”
According to a letter issued to the US Food and Drug Administration department, the recall of Ampicillin 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 of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP).
Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level has been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial.
“AuroMedics Pharma LLC is notifying its distributors and customers by recall letters 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 Sulbactam and Piperacillin and Tazobactam Injections are used to treat infections of different natures at different situations.
Auromedics did not mention the quantities of both the products which are being recalled.
“To date, AuroMedics Pharma LLC 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 manufactured by Aurobindo Pharma Limited at its plant in India, for AuroMedics Pharma, to be distributed in the US.