The Food and Drug Administration has announced the recall of Apotex Corp.’s drospirenone and ethinyl estradiol tablets.
Four lots are affected, and the pills were manufactured by Oman Pharmaceutical Products Co., according to the FDA press release.
The pills were recalled because the tablets may be in the wrong order or there could be an empty blister pocket.
A woman could take a placebo instead of the active tablet.
"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. To date, no case has been reported for pregnancy and adverse event to Apotex."
The impacted lots are the 3MG/03MG dosage of drospirenone and ethinyl estradiol tablets.
These are the affected lots:
All have an expiration date of 8/2020 and have a NDC number on the outer carton of 60505-4183-3. The NDC number on the inner carton is 60505-4183-1.
If you have the affected lots, you are being directed to contact your health care provider. The company says do not stop using the pills, but to augment your birth control with a non-hormonal method.
If you have any questions, call Apotex Corp. at 1-800-706-5573 from 8:30 a.m. to 5 p.m. EST Monday through Friday, or email the company at UScustomerservice@Apotex.com.
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