Why Glenmark, Dr Reddy's are recalling medicines in US
What's the story
Indian pharmaceutical giants Glenmark and Dr Reddy's Laboratories have initiated product recalls in the US. The recalls were announced by the US Food and Drug Administration (USFDA) due to manufacturing issues. Glenmark is recalling an oral contraceptive medication over impurities, while Dr Reddy's Laboratories is recalling a muscle relaxant due to out-of-specification results during stability testing.
Recall 1
Glenmark recalling oral contraceptive medication
According to the latest Enforcement Report from USFDA, Glenmark Pharmaceuticals's US-based unit is recalling 26,928 packs of oral contraceptive medication. The Mahwah, New Jersey-based company is recalling a lot of Viorele, Desogestrel and Ethinyl Estradiol (USP, 0.15 mg/0.02 mg) and Ethinyl Estradiol tablets due to "failed impurities/degradation specifications." The affected lot was manufactured at the company's Goa facility.
Second recall
Dr Reddy's recalling muscle relaxant
Dr Reddy's Laboratories, another major Indian drugmaker, is also recalling a product in the US. The company's Princeton, New Jersey-based subsidiary is recalling 571 vials of Succinylcholine Chloride Injection. This medication is used to provide muscle relaxation during surgery. The recall was initiated due to "out-of-specification results during the 6-month stability testing," according to USFDA.
Recall classification
USFDA classifies recalls as Class II
The USFDA has classified these recalls as Class II. This classification is given when the use or exposure to a violative product may cause temporary or medically reversible health consequences, or when the risk of serious adverse health effects is remote. Notably, India has the biggest number of USFDA-compliant pharmaceutical plants outside America.