HYDERABAD, Apr 18: Aurobindo Pharma Ltd 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 LLC.
“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 Inc 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 indicated to control high blood pressure and used for the treatment of heart failure. (PTI)
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