FDA Reports Recalls Due to Broken Tablets - Pharmaceutical Technology

Latest Issue

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


blog comments powered by Disqus
LCGC E-mail Newsletters

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

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here