A factory error at Alabama company Qualitest Pharmaceuticals is to blame for a recall of certain generic birth control pills this week. The 180-degree mix-up in packaging means the pills were placed in reverse order and are covering the lot number and expiration date in some cases. This mistake can result in unintended pregnancy, because hormone levels vary by day. Women taking the pills in their reverse order will not be getting the correct hormone dosage to ensure effective contraception.There are no immediate health risks associated with this recall; ineffective contraception is the only consequence.
The drug recall affects certain lots of the following birth control pills: Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, and Tri-Previfem. The specific lot numbers, including expiration dates, can be found on this list put out by the company.
Qualitest Pharmaceuticals is a subsidiary of Endo Pharmaceuticals Holdings Inc. (ENDP). The company advises patients taking the recalled pills to enlist non-hormonal contraception, such as condom use, immediately, and see their medical care provider and/or pharmacist. Qualitest has informed pharmacies to begin contacting patients who were given the recalled medication.
“The source of the error is currently under investigation and the company is committed to rectifying the issue in a timely manner,” according to Qualitest’s press release, available on their website.
On June 24 of this year, Endo issued a drug recall for several painkiller/caffeine tablets. Affected were certain supplies of combination acetaminophen, butalbital, and caffeine pills, as well as combination hydrocodone bitartrate and acetaminophen tablets. According to that press release, “this recall was initiated because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg, 1000 count label.” The error meant that patients with affected lot numbers may have ingested a butalbital/caffeine/acetaminophen mix when they intended to take hydrocodone/acetominophen. The only serious health risk posed by the factory error would be if an affected patient had a butalbital allergy. Otherwise, the patient may have experienced worsening pain (from lack of hydrocodone) or dizziness, lightheadedness, or nausea.
That same day, Endo issued another drug recall for incorrect dosage of Endocet oxycodone/acetaminophen tablets. The pills contained in affected bottles were twice the listed dosage. Apparently, 2011 has been a rough year for Endo: September’s birth control recall is Endo Pharmaceuticals’ fourth voluntary recall so far this year. The company has no recalls on record before February 2011, a fact with some scary implications for pharmaceutical patients.
