The US FDA Enforcement Report for the week of February 17 said that the class III voluntary recall is nationwide
US drug firm Sandoz is recalling more than 270,000 bottles of hypertension tablets, manufactured by Hyderabad-based Mylan Laboratories, from the American market, a report by United States Food and Drug Administration (US FDA) said.
Also, unspecified number of bottles of tablets used to treat Parkinson’s disease manufactured by Macleods Pharmaceuticals are also being recalled, according to the US FDA.
As many as 277,267 bottles of Candesartan Cilexetil tablets manufactured by Mylan Laboratories are being recalled by Sandoz, for whom they were made, in an ongoing recall due to ‘failed impurities/degradation specifications; nine-month stability time point,” the report said.
The US FDA Enforcement Report for the week of February 17 said that the class III voluntary recall is nationwide.
The other recall is of Pramipexole dihydrochloride tablets manufactured by Baddi-based Macleods Pharmaceuticals. The product is being voluntarily recalled by Macleods Pharma USA for whom it was being manufactured here.
The class II recall is on account of presence of foreign tablets/capsules in the product, the report said.
The ongoing nationwide class II recall is due to “presence of a comingled Carbimazole 5 mg tablet,” it added.
Class III recall by the US FDA is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
According to the FDA website, a Class II recall is done in a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
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