Lupin recalls oral contraceptives from US market

Mumbai based drug maker Lupin Pharmaceuticals has announced voluntarily recall in United States. Oral contraceptive tablets, Mibelas 24 Fe, of specific dosage have been recalled at the consumer level.

“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,” said US health watchdog, Food and Drug Administration.

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,” US FDA said on its website.

For patients in whom a pregnancy is contraindicated, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death. However, till date there have been no reports of such adverse events, the watchdog clarified.

Indian drug firms, Dr Reddy's Laboratories and Aurobindo Pharma Limited, last month, have separately started recalling few quantities of two different drugs from the US market as they are found to be not up to the mark.

Both the recalls are voluntarily initiated by respective companies, the FDA said.