For the third time this year, a drugmaker is having to recall birth control pills in North America. This time, it is Actavis, which is voluntarily recalling more than half a million boxes of contraceptives because of packaging problems.
According to the most recent FDA Enforcement Report, Allergan's ($AGN) Actavis is recalling 26 lots, amounting to 511,283 boxes, of Lutera birth control pills after discovering that the inserts were missing. The pills were manufactured for Actavis by Patheon, the report indicates.
The Class III recall, which indicates there is no danger to consumers, comes after two other recalls of birth control pills this year in Canada. In April, Johnson & Johnson's ($JNJ) Janssen unit retrieved a single lot of Ortho-Cept tablets because of the potential that the potency of the two active ingredients may not meet specifications, Health Canada reported. The regulator pointed out that as a result, the contraceptive might not be effective and women risked unwanted pregnancies.
A few weeks before the J&J recall, Shoppers Drug Mart in Canada said that because of a supply chain issue at a distribution center, it had released some expired packages of Pfizer's ($PFE) Alesse 21 pills. The problem was the same: Expired pills might not meet specifications and could result in unwanted pregnancies, Health Canada warned. In 2012, Pfizer recalled a million packages of its Lo/Ovral-28 pills and its generic counterparts after the packages were found to have either too many pills with active ingredient or two few.
- here's the recall notice