Pharmaceutical company Dr. Reddy’s Laboratories is recalling a generic version of the antipsychotic Zyprexa, known chemically as olanzapine, because the drug failed impurity and degradation specification testing.
“Due to out-of-specification results for the Related Substance Compound C (Impurity 6 – N-Oxide at the 18 month stability station,” the recall noticed stated. The recall is classified as a Class III, which is a less serious type of recall reserved for products in which use of exposure is not likely to cause adverse health consequences.
Olanzapine was approved by the Food and Drug Administration (FDA) in 2009 under the brand name Zyprexa. It was originally manufactured by Eli Lilly, but has been available through generic manufacturers since 2011. Olanzapine is considered an atypical antipsychotic and is used to treat schizophrenia and bipolar disorder.
The recall affects 5,904 bottles of olanzapine USP 2.5 mg in 30-count bottles manufactured at the DRL plant in Bachupally, Hyderabad, in India.
Any one who has suffered side effects after taking Dr. Reddy’s generic Zyprexa related to this recall should be file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: Economic Times