(WPTA21) — A birth control product is being recalled because of a packaging error that may cause people to take incorrect doses.
The Food and Drug Administration said the recall involves four lots of Drospirenone and Ethinyl Estradiol Tablets. These packages may have defective blisters with incorrect tablet arrangements or empty pockets.
The FDA said due to the packaging error, a patient to miss a dosage or take a placebo instead of an active tablet. This may cause the patient to not get the desired results from the tablets. However, no pregnancies have been reported in connection with the recall.
Anyone who got the birth control tablets that were recalled should contact their pharmacy if they have questions. They should not interrupt their therapy, however.
The FDA is encouraging them to 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.
The affected Drospirenone and Ethinyl Estradiol Tablets, USP lots include the following and can be identified by NDC numbers stated on the inner and outer cartons:
|NDC number on outer carton||NDC Number on inner carton||Lot Number||Expiration Date||Strength||Configuration/Count|
|60505-4183-3||60505-4183-1||7DY008A||8/2020||3MG / 0.03MG||Outer Carton: Contains three inner Cartons
Inner Carton: Contains 1 blister with 21 active yellow color tablets and 7 placebo white color tablets.
The affected Drospirenone and Ethinyl Estradiol Tablets were distributed Nationwide to wholesalers and distributors.