Pregnancy risk warning issued by FDA after Apotex Corp birth control pill 'packaging error'
The Food and Drug Administration has announced the recall of a batch of birth control pills, warning users they could fall pregnant if using the wrongly packaged drugs.
The drugs feature the National Drug Code number 60505-4183-3 on the outside of the box, and 60505-4183-1 inside the carton.They were made by Oman Pharmaceutical Products Co. LLC, a firm subcontracted by the German company Helm AG. Patients who have been given the affected lots or have questions should contact their pharmacy, the FDA said. The agency warned those using birth control “should not interrupt their therapy” and should “use a non-hormonal method of birth control, contact their health care provider for medical advice and may return the impacted packages to their pharmacist.”
Any adverse reactions or problems with the quality of the product can be reported to the FDA via its MedWatch Adverse Event Reporting program. Issues can be reported using the online form at: www.fda.gov/medwatch/report.htm, or by calling 1-800-332-1088 to ask for a form. Faxes can be sent to 1-800-FDA-0178.
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