FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

Merck, BD Facing Issues Over Drug Container Closures

Aug. 27, 2015

Merck is recalling thousands of bottles of Temodar and temozolomide capsules, because cracks in the caps have rendered the child-resistant closure ineffective.

The recall affects roughly 276,000 five- and 14-count bottles of the oral chemotherapy drugs, which were distributed nationwide between July 2013 and August of this year. No adverse events have been reported, according to Merck.

In a similar incident, the FDA is alerting healthcare providers not to use compounded or repackaged drugs that have been stored in 3 ml and 5ml syringes manufactured by Becton-Dickinson, unless there is no alternative. Drugs stored in these syringes may lose potency over time due to a possible interaction with the rubber stopper in the syringe, the agency says.

Providers who use a substitute product may need to adjust the dosage in case patients have been receiving a subpotent product to avoid adverse events, the agency adds. 

To view the Merck recall notice, go to www.fdanews.com/08-21-15-MerckRecall.pdf. The syringe safety alert is available at www.fdanews.com/08-21-15-BDSyringes.pdf. — Kellen Owings