The QMN Weekly Bulletin
Pharmaceuticals / Quality / GMPs

Merck, BD Face Issues With Drug Container Closures

Oct. 9, 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 5 ml 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.

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