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| White placebo pills should be in the Week 13 slot of Sandoz's Introvale--courtesy of the FDA |
In yet another packaging flaw with potential family-planning consequences, Sandoz is recalling contraceptives that have been on the market for nearly 18 months.
In a company release distributed by the FDA this week, Sandoz says it is recalling in the U.S. 10 lots of the generic oral contraceptive Introvale distributed between January 2011 and May 2012. Sandoz is the generics division of Novartis ($NVS). It says the recall was initiated after a consumer discovered the white placebo pill in the row marked Week 9, instead of its rightful place in the row marked Week 13. It says anyone who discovers a misplaced placebo should begin a non-hormonal contraceptive. The placebo is white, while the pills with active ingredient are peach.
In an email today, Sandoz spokeswoman Marija Mandic told FiercePharmaManufacturing the contraceptives were manufactured by a third party but that it was company policy not to disclose more.
There has been a rash of contraceptive recalls and mishaps in the last year because of blister pack problems and other issues.
Glenmark Generics in February recalled 7 lots of Norgestimate and Ethinyl Estradiol tablets manufactured in India, because the pills were rotated 180 degrees in the card. That recall came about a month after Pfizer ($PFE) withdrew a million packages of Lo/Ovral-28 pills and their generic counterparts for a similar packaging mishap.
But packaging has not been the only issue. The FDA in March sent Warner Chilcott ($WCRX) a warning letter saying that for 5 years the potency of its Ovcon pills manufactured at its Fajardo, Puerto Rico, plant have been in question because they failed some of their testing. The company had recalled 7 lots of the pills in June 2011. Last month, Indian drugmaker Lupin began a recall of 10,800 pouches of a contraceptive manufactured in India but distributed throughout the U.S., after a three-month stability test found impurities.
- here's the release from Sandoz and the FDA