BETHESDA, MD 07 June 2012—The generics drug company Sandoz Inc. on Wednesday announced the recall of 10 lots of the oral contraceptive Introvale because of a packaging error reported by a consumer.
Sandoz said the consumer found the product's white placebo tablets in the 9th row of the 13-row blister card rather than in the 13th row. The 9th row is supposed to have peach-colored tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol.
The company advises patients who find a white placebo tablet in any position on the blister card other than the 13th row to immediately start using a form of contraception that does not involve hormones.
These patients, the company added, should also immediately contact their health care professional and report the finding to the Sandoz Drug Information Direct Line at 800-525-2492 or qa.druginfo@sandoz.com.
The recall pertains to the following Introvale lots: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C, and LF01261C. All blister cards in those lots were distributed between January 2011 and May 2012.
Sandoz launched Introvale in the United States on January 5, 2011.
According to the product's labeling, Laboratorios Leon Farma S.A. manufactures Introvale for Sandoz.