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Tuesday, February 28, 2012

birth control recall

birth control recall



birth control recall, Glenmark Generics is issuing a nationwide recall of seven lots of birth control pills. The pills are labeled "norgestimate and ethinyl estradiol tablets."
Because of a packaging error, some of the pills were placed in the wrong order within the packs, according to a statement from the Food and Drug Administration. The packs contain three types of pills with varying levels of hormones, designed to be taken at different times during a woman's cycle.

The pills were rotated 180 degrees within the pack, so the weekly tablet orientation is reversed, and the lot number and expiration date are visible only on the outer pouch, according to the FDA. Any pack for which the lot number and expiry date is not visible is subject to recall.
Because of this error, the daily regimen for these oral contraceptives may be incorrect, leaving women without adequate contraception, and at risk for unintended pregnancy.
These packaging defects do not pose any immediate health risks, but consumers whose pills are affected should begin using a non-hormonal form of contraception immediately, the FDA said. Patients who have the products(lot numbers are provided below) should notify their physician and return the product to the pharmacy.
Lot numbers of affected packs are as follows: 04110101, 04110106, 04110107, 04110114, 04110124, 04110129 and 04110134. The packs were distributed nationwide between Sept. 21 and Dec. 30, 2011. The complete name of the product is 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).
The error was discovered when a consumer complained she received a pack in which the tablets were packaged in reverse order, the FDA said.
In the correct packaging configuration, the top row contains seven white to off-white tablets, and the bottom row contains seven inactive, light green tablets in bottom row.
Last month, Pfizer recalled 28 lots of generic birth control pills labeled Norgestrel and Ethinyl Estradiol tablets, when the company found some packs contained an inexact count of inert or active ingredient tablets, and tablets out of sequence.
More than 1 million packets of birth control pills are being recalled after packages were made with the incorrect dosage of active and inactive tablets. The pills themselves are not dangerous, but taking the incorrect dosage could lead to unwanted pregnancies. The affected drugs include Lo/Ovral-28 tablets and generic Norgestrel and Ethinyl Estradiol tablets that have expiration dates ranging between July 31, 2013, and March 31, 2014.

The drugs in question are manufactured by Pfizer, which already had a bad day on Tuesday, following a disappointing earnings announcement. The company beat income expectations, but announced a drop in both profit and revenue over 2010 numbers and revised the rest of its 2012 earnings downward. The patent on its most popular and lucrative drug, the cholesterol-fighting Lipitor, expired in November, causing sales to fall 42 percent in the United States in just one month.

The pills may also be labeled under the Akrimax Rx Products and Akrimax Pharmaceuticals brand, the company that markets the pills on behalf of Pfizer.
Glenmark Generics Inc. USA today issued a voluntary, nationwide, consumer-level recall of seven (7) lots 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. The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch. Any blister for which the lot number and expiry date is not visible is subject to recall. This packaging error is limited to the seven (7) lots listed in the table below 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. This product is used as an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product (lot numbers are provided below) should notify their physician and return the product to the pharmacy.These tablets were manufactured and packaged by Glenmark Generics Ltd. India. and are distributed by Glenmark Generics Inc. USA. This product is distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011. This product is distributed by Glenmark Generics Inc. only in the USA.
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:
This packaging related issue was discovered when Glenmark received a complaint from a consumer stating that she received one blister pack in which the tablets were packaged in reverse order. The correct packaging configuration of this product has 3 pouch packs packaged in a carton and each pouch pack has one blister which contains 28 tablets (seven tablets each of a different strength and inactive tablets) in which the sequence is white to off-white tablets on top row and inactive light green tablets in bottom row (correctly packaged blister packs are pictured here):
Each white to off white tablet contains 0.18 mg of the progestational compound, norgestimate USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol USP.
Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol USP.
Each blue tablet contains 0.25 mg of the progestational compound, norgestimate USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol USP.

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