FDA Reports Recalls Due to Broken Tablets - Pharmaceutical Technology

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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

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