Once again, there is another birth control recall.
Seems not too long ago, we just wrote about one!
Well, the latest is that the U.S. Food and Drug Administration (FDA) just announced that it’s possible another 8 million birth control pills are involved in a new recall put into effect due to a packaging error which can make the pills ineffective.
The batch of pills were manufactured in India for U.S. distribution, U.S. health authorities said on Monday, February 27.
Seven lots of generic norgestimate and ethinyl estradiol tablets were recalled by Glenmark Generics Inc. USA, according to the Food and Drug Administration, who also said the tablets were manufactured and packaged by Glenmark Generics Ltd. India and distributed to wholesalers and retail pharmacies across the United States between Sept. 21, 2011 and Dec. 30, 2011.
“As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy,” Glenmark said in a statement.
It was not immediately clear how many packets were affected by the error, which rotated some of the pills by 180 degrees out of the usual sequential order and left the lot number and expiration date visible only on the outer pouch.
“Any blister for which the lot number and expiry date is not visible is subject to recall,” Glenmark added in a statement.
The problem was discovered when Glenmark received a consumer complaint that she received one blister pack in which the tablets were packaged in reverse order. The correct packaging configuration is of three pouch packs packaged per carton; each has one blister which contains 28 tablets.
Women who may have been taking the pills are urged to immediately begin using a non-hormonal form of contraception, as well as inform their health care provider immediately. They should also take a pregnancy test if they have any symptoms of pregnancy, and return the product to the pharmacy of purchase.
“This is extremely disturbing,” stated Steven Goldstein, an obstetrician-gynecologist at NYU Langone Medical Center, and professor at the NYU School of Medicine, adding the recall raised new concerns about the safety of foreign-made generics.
“This problem with generics manufactured outside of the USA is of great concern to me as a clinician. I often allow and encourage patients to try generics as long as they do not have nuisance side effects. However, I have always assumed them of equal quality control to the branded products.”
Glenmark Generics has operated its manufacturing plant in India since 2003. The recall is the third to affect U.S. consumers in the past six months involving contraceptives.
On Feb. 1, U.S. pharmaceutical giant Pfizer recalled one million packets of birth control pills over a similar packaging error, though those pills were manufactured in the United States. According to experts familiar with the matter, women who become pregnant after taking the defective birth control pills and could sue big. Pfizer stated the issue was the result of mechanical and visual inspection failures that occurred on the packaging line, a problem Pfizer says has since been corrected.
A separate recall was issued in September 2011 by the pharmaceutical company Qualitest in Alabama, due to packaging errors that affected 1.4 million packets of birth control pills distributed in 2011.
The more and more we write about the dangers and troubles with birth control the more and more I am convinced that Family Planning may be the best method!