WASHINGTON (NEWS10) – Lupin Pharmaceuticals announced a nationwide recall of Mibelas 24 Fe, a chewable birth control tablet.
The recall stems from a packaging error where the tablets were placed out of sequence.
The Food and Drug Administration (FDA) says this may increase the risk for contraceptive failure and unintended pregnancy.
To date, there have been no reports of adverse events.
The affected products were packaged in blister packs containing 28 tablets: 24 white to off-white tablets of active ingredients with “LU” stamped on one side and “N81” on the other, and four tablets of inert ingredients were stamped with “LU” on one side and “M22” on the other side.
|68180-911-11 (Wallet of 28 tablets)
68180-911-13 (Carton of 3 wallets)
The affected products were sent to wholesalers, clinics, and retail pharmacies across the country.
Consumers with questions or concerns should contact Lupin by phone 1-800-399-2561, 8 a.m. to 5 p.m., Monday through Friday.
Anyone with health-related concerns or who have experienced problems that may be related to taking this drug should contact their health provider.