Actavis contraceptives recalled after packaging errors

pharmafile | July 9, 2015 | News story | Manufacturing and Production Actavis, FDA, manufacturing, packaging, product recall, production, recalls 

Actavis is voluntarily recalling more than half a million boxes of contraceptive pills in the United States due to problems with the packaging of the medicines.

According to the FDA Enforcement Report, Actavis is recalling 26 lots, amounting to 511,283 boxes of their Lutera (levonorgestrel/ethinyl estradiol) contraceptive pills after learning they were distributed with out-dated package inserts. The pills were manufactured for Actavis by contract manufacturer Patheon.

The Class III recall indicates that there is no danger to consumers and comes after two other recalls of birth control pills this year in Canada.

In April Johnson & Johnson recalled a single batch of Ortho-Cept (desogestrel ethinyl/estradiol) tablets due to the potential that the potency of the two active ingredients may not meet specifications, according to Health Canada. As a result, the regulator pointed out that contraceptive might not be effective, and that women were at risk of unwanted pregnancies.

In 2012, Pfizer recalled a million packages of its Lo/Ovral-28 (ethinyl estradiol and norgestrel) pills after the packages were found to have either too many pills with active ingredient or too few. It followed a warning issue from Health Canada who stated the expired pills might not meet specifications and could result in unwanted pregnancies.

Yasmita Kumar

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