FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

Merck, BD Facing Issues Over Drug Container Closures

Aug. 27, 2015
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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