Lupin Pharmaceuticals has announced the voluntary recall of a batch of Mibelas 24 Fe (norethindrone acetate and ethinylestradiol) 1mg/0.02mg chewable tablets and ferrous fumarate 75 mg) tablets. The medication is a oral contraceptive and taking the tablets in an incorrect order may place users at risk for contraceptive failure and unintended pregnancy.
The product was distributed across the United States to pharmacies, clinics and wholesalers. The US Food & Drug Administration (FDA) has advised users taking the affected medication to consult their physician and return the product to the retailer or pharmacy from which they were purchased.
The voluntary recall is due to a packaging error obscuring the expiration date and lot number. In the affected packaging, the blister is rotated 180 degrees, reversing the weekly tablet orientation, changing the first four tablets to four non-hormonal placebos.
The tablets come in blister packs with 28 tablets: 24 white to off-white tablets marked with LU and N81 on either side (the active tablets); and four tablets marked LU and M22 (with inert ingredients).
Affected Products:
NDC
68180-911-11 (Wallet of 28 tablets)
68180-911-13 (Carton of 3 wallets)
Lot number Expiration:
L600518 05/31/2018
Consumers have been warned new users and patients who have been taking the medication for some time may not immediately spot the error. This increases the risk tablets will be taken in an incorrect order, compromising their efficacy. Patients for whom pregnancy is a contraindication have been urged to take particular care. Lupin Pharmaceuticals has already taken action to notify both distributors and consumers by letter and is arranging for all affected medication to be recalled.
Mibelas 24 FE is an oral contraceptive combining two female hormones: estrogen and progestin. Progestogen-only contraceptives such as Lyza, and monophasic contraceptives such as Wera or Lutera are also used as birth control. Patients who wish to avoid unwanted pregnancy have a number of birth control options, including: hormone patches, hormone injections, long-acting intrauterine devices (IUDs) and hormonal implants, vasectomies and condoms. According to figures from the Centers for Disease Prevention and Control, condoms are the most commonly used form of birth control in the US, while eight out of ten women had used contraceptive pills at some point in their lives.
