More recalls, more recalls, more recalls. If I were on a birth control pill, I would be nervous right about now about a potential pregnancy. We have previously reported that we have had 3 birth control recalls within the last few months, and now we have another to add to the list!
Introval birth control pills are being recalled for packaging errors, the U.S. Food & Drug Administration (FDA) has announced. This is not the first time birth control pills have been recalled over packaging problems.
Sandoz is recalling 10 lots of its generic oral contraceptive Introvale® following a report of a packaging flaw. Sandoz indicated that it is not aware of any adverse events related to this recall. The lot numbers involved are: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C, and LF01261C. The recalled lots were distributed in the U.S. between January 2011 and May 2012.
A consumer reported that the prescription’s white placebo tablets were mistakenly located in the ninth row—which is labeled “Week 9″—in the 13-row blister card. The placebos correct position is the final row labeled “Week 13.” The three-month blister cards contain 84 peach-colored active tablets and seven white placebo tablets in 13 rows. Each row represents one week.
Although the white placebo tablets are clearly distinguishable from the peach-colored active tablets, the risk of an unintended pregnancy exists if a patient takes the wrong tablet over several days.
Within the latest news involving birth control pills, we found out that the FDA issued a warning letter to Warner Chilcott, the maker of Ovcon birth controls pills, over faulty birth control pills. According to the agency, for five years, Ovcon’s potency has been questionable, creating a pregnancy risk to women.
The FDA previously conducted an inspection of Warner Chilcott’s Fajardo, Puerto Rico manufacturing plant. From 2006 to the June 2011 recall, the FDA, among other issues, said problems existed that may result in the Ovcon pills not lasting until their expiration date.
And the other recalls, we were told that over 8 million pills of Norgestimate and Ethinyl Estradiol Tablets USP were faulty due to packaging errors, that could render the daily regimen for these oral contraceptives incorrect, leaving women with inadequate contraception, and at risk for unintended pregnancy.
We also previously wrote that Pfizer recalled 1 million birth control pill packages and could be facing lawsuits. A packaging problem was also to blame in that case.
According to experts familiar with the matter, women who become pregnant after taking the defective birth control pills could sue Pfizer for their unwanted pregnancies, and could sue big. The issue is the same in the Glenmark recall and Warner debacle.
So, what do you need to do if you take the pills listed in this recall? Should a patient discover a white placebo tablet in any position other than the 13th and final row—Week 13—she should immediately begin using a non-hormonal form of contraception and contact her healthcare professional and Sandoz to report the finding.
And, if you are on any other oral contraceptives…it might just be best to use an alternative form of birth control at the same time! The track record for birth control pills lately isn’t looking so good!