Drug manufacturing giant Allergan has issued a nationwide recall for one lot of the oral birth control Taytulla, after a doctor tipped them off that a recent pack’s pills were arranged in the wrong order.
The cringe-worthy packaging mistake is estimated to have affected 170,000 one-month pill packs that were distributed across the US last year as samples for medical offices to give patients.
Though the error does not compromise the safety of the product, like any oral birth control medication, the pills are only effective if they are taken in a certain order relative to a patient’s menstrual cycle. A new 28-day pack is supposed to feature 24 days' worth of active hormone pills – in this case, a combination of synthetic progesterone and estrogen – followed by four days' worth of placebo pills. In the botched lot of Taytella, the four placebo pills – easily identifiable by their contrasting color – are at the beginning of the pack.
“As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy,” states the Food and Drug Administration Alert recall announcement. They advise anyone who received a sample pack after August 2017 to check the lot number listed on the packaging. The affected lot number is 5620706, with an expiration date of May 2019.
“The reversing of the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order.”
Yet to anyone who is familiar with the product, the mixed-up ordering would be glaringly obvious. And given the intense level of process review and inspection that is required for drugs being made for US consumers, it’s worrisome that the lot – an industry term for a specific batch – left the manufacturing warehouse in the first place.
Despite how rare these events should be in an ideal world, yesterday’s recall marks the second time such a mistake has occurred in less than a year. Last June, Lupin Pharmaceuticals issued an alert after discovering the pills in one lot of Mibelas 24 Fe oral birth control pills were also in the wrong order. Coincidentally, Mibelas uses a similar formulation of to Taytulla.
Thanks to the publicity nightmare currently unfolding for Allergan, it’s fair to say that their sample packs failed to create a good first impression of the brand.