Sandoz Inc, Macleods Pharma recall two drugs made in India
New York: US drug firm Sandoz Inc is recalling over 2,70,000 bottles of hypertension tablets, manufactured by Hyderabad-based Mylan Laboratories, from the American market, a report by USFDA has 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 USFDA.As many as 277,267 bottles...
Also, unspecified number of bottles of tablets used to treat Parkinson's disease manufactured by Macleods Pharmaceuticals are also being recalled, according to the USFDA.
As many as 277,267 bottles of Candesartan Cilexetil tablets manufactured by Mylan Laboratories are being recalled by Sandoz Inc, for whom they were made, in an ongoing recall due to "failed impurities/degradation specifications; 9 month stability time point," the report said.
The USFDA Enforcement Report for the week of February 17, 2016 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 Inc 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 United States Food and Drug Administration (USFDA) is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
As per 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.