A 28-day dosing regimen, Ovcon 35 is packed in a foil-based blister pack consisting of four horizontal rows of seven tablets each, with each row representing a one-week dosing regimen. Normally, the first three rows, representing weeks one through three, should contain peach-colored tablets, which contain the active ingredient. The fourth row, representing week four, has green-colored placebo tablets. The company reports that six packages-all within the same lot-have been discovered containing the green placebo pills positioned in the first row instead of the last, potentially undermining the drug's effectiveness. Bristol-Myers Squibb isn't saying what actually happened. But Jane A. Kramer, director, public policy, tells PW that machinery problems weren't necessarily the cause; rather "it was more processes . . . it was a confluence of events." The company states that the recall is restricted to only one lot, which consisted of over 200ꯠ packages. However, some 53ꯠ packages were still in inventory. The company says it has already taken corrective action to prevent a recurrence.
Bristol-Myers recalls birth control packages
In mid-January, New York-based Bristol-Myers Squibb voluntarily recalled about 150ꯠ packages of its Ovcon® 35 birth control tablets due to a packaging snafu that might increase the risk of an unwanted pregnancy.
Feb 28th, 1997