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Dawn Stacey M.Ed, LMHC

New Birth Control Pill Recall: Does it Affect You?

By February 29, 2012

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If you are currently taking the combination birth control pill, Norgestimate and Ethinyl Estradiol Tablets (generic form of Ortho Tri-Cyclen) or know anybody who is, listen up! Glenmark Generics Inc. has just announced that the company has issued a voluntary, nationwide recall of seven  lots of their phasic Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.

Glenmark realized that there was a problem with the pill's packaging after receiving a costumer complaint that she received a blister pack where the pills were packaged in the reverse order. The company explains that these 7 lots contained blisters that were rotated 180 degrees within the card -- thus reversing the weekly pill schedule and making the lot number and expiry date visible only on the outer pouch. If you can't see the lot number and expiration, your pill pack is subject to the recall.

Because these are considered to be a phasic combination pill, there are different amounts of the progestin, norgestimate, in each week of the pill pack. If you take these pills out of order, you may be more at risk for birth control failure. The FDA is asking that if you have been using one of these blister packs, you should start using a non-hormonal birth control method, notify your doctor and return the pill pack(s) to the pharmacy. It is important to note that this packaging error doesn't pose any immediate health risks. Given that you may be at an increased pregnancy risk, if you have discovered that your pill pack is part of this recall and have had sex in the past 5 days (120 hours), it may be a smart idea to use emergency contraception for added protection.

These pills should be packaged in a blister pack that contains 28 pills:

  • Week 1 (top row): 7 off-white pills
  • Week 2 (second row): 7 light blue pills
  • Week 3 (third row): 7 blue pills
  • Week 4 (bottom row): 7 inactive light green pills

The recalled pill lots were distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011. The following lot numbers are involved in the recall:

  • Lots: 04110101; 04110106; 04110107 - these 3 lots have the expiration date: 07/31/2013
  • Lots: 04110114; 04110124; 04110129 - these 3 lots have the expiration date: 08/31/2013
  • Lot: 04110134 with the expiration date: 09/30/2013
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