A defect in the packaging has prompted Sandoz to issue a voluntary recall of ten lots of a product known as Introvale. This drug is a generic oral contraceptive, and the affected versions of the product were distributed throughout the country. Although the chances of this error posing health risks are reportedly small, and no adverse reports have been reported as yet, the company is carrying out the recall as a precaution. Consumers who do find themselves experiencing an adverse reaction on account of using the product are urged to report the matter to the FDA’s MedWatch Adverse Event Report program. Doctors should also obey this directive if their patients have sustained an adverse report due to the product.
The defect in packaging has to do with the placement of a row of placebo tablets. The product consists of thirteen rows of tablets, twelve rows containing the peach-colored Introvale and one row containing white placebos. This placebo row is supposed to be the last row, so that persons taking the drug know to take the placebo tablets in the 13th week. However, a consumer recently described how that placebo row wasn’t in the final row but rather the 9th row. If a female patient were to thus take the placebo in the ninth week, it becomes possible that the birth control could fail and the woman could become pregnant by accident.
Anyone who discovers the issue is being advised to switch over to a non-hormal contraceptive at once and to consult a doctor about the issue.