Introval birth control pills are being recalled for packaging errors, the U.S. Food & Drug Administration (FDA) just 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.
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. The Sandoz Drug Information Direct Line can be reached, toll-free, at 1.800.525.2492, 24 hours daily, seven days a week, or by email at: email@example.com.
We previously wrote 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.
That news followed two other reports of faulty birth control pills that led to recalls. We previously wrote that 8 million birth control pills were involved in a recall implemented over a packaging error. In that case, Glenmark Generics Inc. recalled seven lots of Norgestimate and Ethinyl Estradiol Tablets USP because some of the packaging blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and rendering the lot number and expiry date visible only on the outer pouch. This packaging error 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.