Hyderabad: Hyderabad-based Aurobindo Pharma has initiated recall of 88,600 vials of Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL) from USA market as one of the vials contained a strand of hair, the US Food and Drug Administration said. According to a notification put up by the US Drug regulator in its website, these vials were manufactured in India for AuroMedics Pharna.
“Reason for Recall: Presence of Particulate Matter: One vial was found to contain a hair,” it said. Lidocaine HCl injection is a medication used for local or regional anaesthesia to perform certain surgeries and procedures.
The product is being held at a distributor site in Mexico, Asheboro and Charlotte, North Carolina , and Santa Teresa, New Mexico and not further distributed in the US Market, the FDA notification said.
Aurobindo Pharma USA has recently initiated recalling some lots of Valsartan tablets in various strengths due to “presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the active pharmaceutical ingredient (API) which used to manufacture the product.” Valsartan Tablets USP are used in the control of high blood pressure and used for the treatment of heart failure.