Link to FDA website, regarding recalls. PRODUCT
TriNessa (Norgestimate and Ethinyl Estradiol) Tablets, Oral Contraceptive, packaged in unit dose PVC blisters with an aluminum foil backing, Rx only, NDC 52544-935-28, Recall # D-190-6
CODE
Lot -- Exp: 4CM613 -- MARCH 2006;
4CM614 -- MARCH 2006;
4KM005 -- AUGUST 2006;
4LM024 -- AUGUST 2006;
4LM025 -- AUGUST 2006;
4LM048 -- AUGUST 2006;
4MM101 -- SEPTEMBER 2006;
4MM109 -- SEPTEMBER 2006;
4MM110 -- OCTOBER 2006;
5AM165 -- OCTOBER 2006;
5AM166 -- OCTOBER 2006;
5CM286 -- JANUARY 2007;
5CM294 -- JANUARY 2007;
5CM295 -- JANUARY 2007;
5DM359 -- FEBRUARY 2007;
5EM416 -- MARCH 2007;
5GM426 -- FEBRUARY 2007;
5GM443 -- FEBRUARY 2007;
5GM477 -- APRIL 2007;
5JM547 -- MAY 2007;
5KM623 -- MAY 2007;
5LM657 -- MAY 2007;
5LM658 -- SEPTEMBER 2007
RECALLING FIRM/MANUFACTURER
OMJ Pharmaceuticals, Inc., Manati, PR, by letters on February 9, 2006. Firm initiated recall is ongoing.
REASON
Subpotent: The active Norgestimate component of TriNessa tablets fails stability assay.
VOLUME OF PRODUCT IN COMMERCE
1,383,709/6 packs
DISTRIBUTION
Nationwide
The Rundown:
Basically, a few lots of this birth control pill, TriNessa, are not effective, because the hormone that makes them work is missing from the lot. If you are taking this pill for birth control, please read this and make sure the pack you have does not fall under these lots-the pills will not work! However, since the missing hormone does not make this drug fatal, the FDA is not requiring that the drug companies/pharmacies tell anyone that's been taking this. They were only told to pull the remaining packs off the shelves. So please, pass this on, so that anyone who's taking it will get help, and not have an unfortunate accident.