Lupin Pharmaceuticals has announced a nationwide recall on one lot of its oral contraceptive Mibelas 24 F-E tablets after a consumer noticed a packaging error.
According to the FDA, the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation, making it so that the first four tablets in the package would be non-hormonal placebo tablets as opposed to the active tablets.
According to a statement released by Lupin, a consumer may be at risk for contraceptive failure and unintended pregnancy. However, no issues have been reported at this time.
The recalled tablets are packaged in blister packs containing 28 tablets: 24 white to off-white tablets that contain active ingredients with “LU” on one side and “N81” on the other; and 4 inactive tablets with “LU” on one side and “M22” on the other.
National Drug Code (NDC) Lot No. Expiration
68180-911-11 (Wallet of 28 tablets) L600518 5/31/2018
68180-911-13 (Carton of 3 wallets) L600518 5/31/2018
Consumers with the affected contraceptive should contact their physician and return it to the pharmacy.
Consumers with questions regarding the recall can contact Lupin at 1-800-399-2561 Monday through Friday.
Consumers should contact their physician if they have experienced any problems that may be related to taking the contraceptive.