FDA Reports Recalls Due to Broken Tablets

News
Article

Discovery of split and broken tablets led to drug recalls.

FDA reported recent recalls of prescription drugs due to broken or split tablets in an enforcement report. The recalls were voluntarily initiated by the manufacturers and involved prescription products only.

One lot (lot #JKM7075A) of oxcarbazepine tablets (300 mg, 100 tablet bottles) distributed by Caraco Pharmaceutical Laboratories (Detroit, MI) and manufactured by Sun Pharmaceutical (India) was recalled. The recall was initiated after investigation into complaints found the potential for this lot to contain broken tablets, according to the recall notice.

In addition, bottles from lot# 605957A of diclofenac sodium and misoprostol delayed-release tablets (75 mg/0.2 mg, 60-count bottle) manufactured by Watson Laboratories, now Actavis (Corona, CA), were voluntarily recalled. The recall was initiated because split tablets were found in the 12-month stability samples.

Source: FDA

Recent Videos
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes