Apotex Corp. has recalled four lots of birth control pills for packets having defective blisters with incorrect tablet arrangements and empty blister pockets.
The pharmaceutical company recalled the drospirenone and ethinyl estradiol tablets after defective packaging was found that could result in a patient taking a placebo instead of an active tablet, or vice versa, according to a news release. There are also packets that have missing pills, which would result in the birth control losing efficiency.
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There have been no cases of pregnancy or adverse events reported, officials said. The affected tablets were distributed nationwide to wholesalers and distributors.
The four affected lots include 7DY008A, 7DY009A, 7DY010A and 7DY011A. Each packet will have an expiration date of 8/2020. An NDC number of 60505-4183-3 will be on the outer carton and an NDC number of 60505-4183-1 will be on the inner carton.
Officials said patients who have received impacted pills should not stop taking the medication. They should follow up the birth control with a non-hormonal method and may also return the impacted packages to their local pharmacist.
If a user experiences adverse affects, the Food and Drug Administration advises them to file a report online here; or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form. The form may also be faxed to 1-800-FDA-0178.
For more information, 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.