Lupin Pharmaceuticals announces nationwide recall of Mibelas 24 Fe tablets

Mibelas 24 Fe (Photo: Business Wire).

Recall due to out of sequence tablets and missing expiry/lot information.

A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.

As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy. The reversing the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the tablets out of order. For patients in whom a pregnancy is contraindicated or in whom concomitant medication(s) may have teratogenic effects, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death. To date there have been no reports of such adverse events.

This product is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives. These products are packaged in blister packs containing 28 tablets: 24 white/off-white tablets of active ingredients debossed with “LU” on one side and “N81” on the other; and 4 tablets of inert ingredients debossed with “LU” on one side and “M22” on the other side. This product was distributed Nationwide in the US to wholesalers, clinics and retail pharmacies.