Mumbai, India (4E) – Ranbaxy Laboratories Ltd. has announced another recall of generic versions of the anti-cholesterol drug Lipitor in the U.S. market because of a possible mix-up in the dosage labeling.
Ranbaxy, the India-based generic-drug maker troubled with manufacturing-quality problems, is recalling 64,626 bottles of atorvastatin calcium pills following a “product complaint” was reported to a pharmacist, according to the U.S. Food and Drug Administration.
The pharmacist said a 20-mg tablet pill was found in a sealed bottle marked for 10-mg pills, according to the FDA.
In the FDA website, the recall was classified as “Class II,” which means the product may result to medically reversible or temporary health problems, or there is a remote probability of a serious health problem.
Ranbaxy spokesman Gaurav Chugh said in an e-mailed statement that the actual “voluntary recall” occurred in January this year.
Citing deficiencies such as faking of quality-test results by plant workers, the U.S. FDA disallowed Ranbaxy, a unit of Tokyo-based Daiichi Sankyo Co., from selling drug ingredients made at a plant in Toansa, India to the U.S. market in January.