From Our 2012 Archives

New Birth Control Pill Recall

Glenmark Generic Birth Control Pills Packed in Reverse Order

By Daniel J. DeNoon
WebMD Health News

Reviewed by Laura J. Martin, MD

Feb. 27, 2012 -- Seven lots of generic birth control pills have been recalled by Glenmark.

It's the second recall of birth control pills in one month. The new recall is not linked to the previous recall of Pfizer birth control pills.

The pills recalled by Glenmark, made and packaged in India, must be taken in order -- but the recalled packages are put together backward. This means women may take the wrong pills on the wrong day, putting them at risk of unwanted pregnancy.

Women who have taken the recalled product should be aware of the signs of early pregnancy.

Other than unwanted pregnancy, the recalled birth control pills pose no new immediate health risks.

"Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately," Glenmark says in a news release. "Patients who have the affected product ... should notify their physician and return the product to the pharmacy."

Because of the packaging error, the lot number and expiration date is visible only on the outer pouch of the product. If the lot number and expiration date can't be read on the blister pack, the product is being recalled.

The pills were distributed in the U.S. from Sept. 21, 2011, through Dec. 30, 2011. They were distributed only in the U.S.

Recalled Birth Control Pills

The packages carry the Glenmark brand in the lower right corner. The generic name of the drug is printed across the top: "Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg."

Lot numbers of affected packs are as follows:

NDC

Lot Numbers

Expiration

68462-565-29

04110101

07/31/2013

68462-565-29

04110106

07/31/2013

68462-565-29

04110107

07/31/2013

68462-565-29

04110114

08/31/2013

68462-565-29

04110124

08/31/2013

68462-565-29

04110129

08/31/2013

68462-565-29

04110134

09/30/2013

The correct packaging configuration of this product has three pouch packs in a carton and each pouch pack has one blister that contains 28 tablets. The correct tablet sequence is white to off-white tablets on the top row and inactive light green tablets on the bottom row:

  • Each white to off white tablet contains 0.18 mg of the progestin compound, norgestimate USP, together with 0.035 mg of the estrogen compound, ethinyl estradiol USP.
  • Each light blue tablet contains 0.215 mg of the progestin compound, norgestimate USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol USP.
  • Each blue tablet contains 0.25 mg of the progestin compound, norgestimate USP, together with 0.035 mg of the estrogen compound, ethinyl estradiol USP.
  • Each light green tablet contains inert ingredients only.

SOURCES: News release, FDA.News release, Glenmark Generics Inc.

©2012 WebMD, LLC. All Rights Reserved.




STAY INFORMED

Get the Latest health and medical information delivered direct to your inbox!