Ranbaxy Issues Voluntary Nationwide Recall of Atorvastatin Calcium

Statin lots may contain very small glass particles

/ Author:  / Reviewed by: Joseph V. Madia, MD

On November 9, 2012, Ranbaxy Inc. initiated a voluntary recall of 41 affected lots of atorvastatin calcium tablets (10 mg, 20 mg and 40 mg) which is a solid oral dosage form, to the retail level.

The company is taking this voluntary action as a precautionary measure due to the fact that they cannot exclude the possibility that the affected lots may contain very small glass particles resembling a fine grain of sand (less than 1 mm in size).

This information is available in Ranbaxy’s website at www.ranbaxyusa.com. The recall does not affect or relate to the 80 mg dosage strength of atorvastatin calcium tablets.

The probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out. Because of the size of the particles which may be present in the affected lots, it is unlikely to cause a significant safety concern.

However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out. As of this date, Ranbaxy has not received any reports of adverse events related to this recall.

The product is used to lower blood cholesterol and is packaged in plastic bottles, as 90 and 500 tablets per bottle. The affected lots of atorvastatin calcium tablets and their respective NDC code, expiration date information are listed below.

The product is a white colored tablet and can be identified by the imprint RX12 on 10 mg tablets, RX828 on 20 mg tablets and RX829 on 40 mg tablets. The product was distributed in the USA to wholesalers and retailers.

Ranbaxy has notified its distributors and retailers by e-mail/ FedEx and has arranged for return of the affected lots. Distributors/retailers have stopped further distribution of the affected lots and are in the process of returning any affected product to Ranbaxy.

Consumers with questions regarding this recall can contact Ranbaxy’s Customer Coordinator (Inmar) at 1-866-266-7623, Monday to Friday, 8:00 AM to 5:00 PM CST. Consumers should immediately contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the US Food and Drug Administration. The affected lots can be identified in the link to the FDA website below.

Reviewed by: 
Review Date: 
November 29, 2012