The Food and Drug Administration (FDA) has announced the recall of birth control pills and issued a warning that users could fall pregnant if using the wrongly-packaged pills.
Apotex Corp., a drug firm, reported the possible defects with Ethinyl Estradiol and Drospirenone tablets, which have been distributed across the country. Some of the affected packets have missing pills, while others have wrongly arranged tablets.
The following lot numbers have been affected by the recall: 7DY009A, 7DY008A, 7DY010A and 7DY011A. Each lot has an expiration date of August 2020 and strength of 3MG/0.03MG.
The affected drugs have the National Drug Code number 60505-4183-3 on the outside of the box, and 60505-4183-1 inside of the carton. The drugs were manufactured by Oman Pharmaceutical Products Co. LLC, a firm that was subcontracted by Helm AG.
The combined oral contraceptive pills contain estrogen and progestin, and are taken to prevent pregnancy.
In a statement, the FDA warned that, “As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed.”
No cases of pregnancy have been reported to Apotex, according to the FDA.
Users with affected lots who have questions should contact their pharmacy, the agency said. The FDA says users should “not interrupt their therapy” and should rely on a “non-hormonal method of birth control.” The impacted packages can be returned to the pharmacist.
Adverse side effects should be reported to the FDA through its MedWatch Adverse Event Reporting program (www.fda.gov/medwatch/report.htm). Individuals with questions can also contact Apotex Corp.
Apotex Corp. has contacted wholesalers and distributors who have received the faulty drugs, and cautioned that they should be sent back to where they were purchased.