- In fall 2011, Qualitest, a subsidiary of Endo Pharmaceuticals, recalled eight brands of oral contraceptives. The reason: A packaging error in which the top row (active hormonal) and the bottom row (placebo) were mixed up. As a result, there were 113 unintended pregnancies in 26 states, according to a class-action suit filed in a Pennsylvania State Court.
- The suit is seeking millions of dollars in damages and is intended to cover many different costs related to unintended pregnancies, such as the cost of raising a child to adulthood.
- Additionally, the lot number and expiry date were no longer visible due to the turnabout in the packaging.
The Academy of Managed Care Pharmacy (AMCP) categorizes packaging errors under the umbrella of medication errors, which it calls "a major public health concern."
The birth control products named in the suit included one or more types of Cyclafem; Emoquette; Gildess; Orsythia; Previfem; and Tri-Previfem. Although a total of 1.4 million packages were recalled, Endo only confirmed one defective pack was sold to a customer. Apparently, the defective packaging occurred at an external manufacturing facility.