Aurobindo recalls 88k Lidocaine injections from US
The company recalled them due to the presence of a hair strand
Aurobindo Pharma has initiated recall of 88,600 vials of Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL) from the US 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, Charlotte, North Carolina , Santa Teresa and New Mexico, and is not being further distributed in the US Market, the FDA notification said.
Aurobindo Pharma USA Inc has also 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 is used to manufacture the product.” Valsartan Tablets USP are indicated to control high blood pressure and used for the treatment of heart failure.