News

Article

Lupin Recalls Mibelas 24 Fe

The company recalled the tablets due to a packaging error.

On May 25, 2017, Lupin Pharmaceuticals Inc. announced it was voluntarily recalling lot L600518, Exp 05/18 of its contraceptive, Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) tablets. The recall was enacted after the company received a complaint of a blister pack rotated 180 degrees in the wallet, which reversed the weekly tablet orientation and reduced the visibility of the lot number and expiration date.

The packaging error is significant because the first four days would have had placebo tablets instead of active tablets. The company stated that users may not notice the reverse order, which could cause contraceptive failure and unintended pregnancy. The product is packaged in blister packs of 28 tablets: 24 white to off-white tablets containing active ingredients debossed with LU on one side and N81 on the other side and four tablets of inert ingredients debossed with LU on one side and M22 on the other side.

Source: FDA

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content