Johnson & Johnson is recalling more than 32 million packages of birth control pills sold outside the United States, as the company continues to face quality control problems that have impacted a number of different medications and products in recent years.
The New Brunswick, New Jersey based company recalled Cilest birth control pills this week due to solubility issues.
Following routine testing last month, it was found that one of the active hormones in the contraceptive, norgestimate, dissolved too slowly. This could decrease the effectiveness of the birth control pill and result in a risk of unplanned pregnancy,
A recall has been issued for 179 batches distributed to 43 countries in Europe, Asia and Latin America. The birth control pills were not sold in the United States. The recall was issued at the wholesale and pharmacy level and will not be recalled from consumers, as Johnson & Johnson indicates that the problems pose a low-risk of causing unplanned pregnancies for women.
Continuing Johnson & Johnson Concerns
This recall is yet another in a long line of more than 40 product recalls which have burdened the global medical product company since 2009. Many of the recent Johnson & Johnson recalls have involved non-prescription medications, such as the Tylenol recalls, but some involved prescription medications, contact lenses and other products.
Earlier this year, Johnson & Johnson issued a recall for the One Touch Verio IQ Blood Glucose Meter after the company discovered the product often shut off instead of giving proper blood glucose readings, often after high levels of glucose detected.
Johnson & Johnson also recalled more than 2 million containers of K-Y Jelly lubricant earlier this year after the FDA notified the company the product was not approved for the market.
In 2010, a number of quality control problems were found at a Johnson & Johnson manufacturing plant, resulting in a shutdown of one of its major production facilities. More than 136 million bottles of Tylenol, Benadryl and Motrin were removed from the market as a result of the problems.
Other Birth Control Problems
The Cilest contraceptive recall also follows many recent recalls involving manufacturing problems with birth control pills made by other companies.
In April, the Canadian distributor Apotex issued a recall of the birth control pill Alysena 28. The recall was issued after packages were discovered which contained two weeks worth of placebo pills, instead of only one week. The recall was upgraded to a type 1 recall, the most serious type of recall, considering the mistake placed many women at risk of becoming pregnant.
Last year, Sandoz issued a recall for the birth control pill Introvale after the placebo pills were found in the incorrect row of the packaging. It was yet another product packaging mistake which exposed many women to the risk of unwanted pregnancies.
Amid the packaging mistakes and recalls, a product liability lawsuit was filed recently against Qualitest Pharmaceuticals after a Missouri woman became pregnant in 2011. The woman took defective birth control pills which were mislabeled and placed in the packaging in the wrong order, causing her to become pregnant.