A recall has been announced of seven lots of Norgestimate and Ethinyl Estradiol Tablets, due to a packaging error, causing the possibility for the pills to be out of sequence.
The affected pills are the Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. It has been determined that the blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation. This has additionally caused the lot number and expiration date to be visible only on the outer pouch.
This product is used as an oral contraceptive indicated for the prevention of pregnancy. Though the packaging defect does not pose a health risk, the packaging error can cause the daily regimen to be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
Lot numbers of affected packs of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic), are as follows:
Lot Numbers – Expiration Date:
- 04110101 – 07/31/2013
- 04110106 – 07/31/2013
- 04110107 – 07/31/2013
- 04110114 – 08/31/2013
- 04110124 – 08/31/2013
- 04110129 – 08/31/2013
- 04110134 – 09/30/2013