FDA Reports Recalls Due to Broken Tablets - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Reports Recalls Due to Broken Tablets


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

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
43%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Click here