Merck · Recalled
Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child-Resistant Closure Requirement
The bottle cap can be cracked which can cause the child-resistant closure to become ineffective to young children who can gain unintended access to the capsules, posing a risk of poisoning.
- Units
- About 276,000
- Reports
- —
- Injuries
- —
- Deaths
- 0
- Price
- —
- Remedy
- Replace
Reports, injuries, deaths and price are read out of the notice’s wording by rules, so they can miss unusual phrasing. The official notice is the record.
Affected
This recall to replace involves bottle caps for Temodar and Temozolomide (generic) capsules, an oral chemotherapy drug. The capsules were distributed in 5- and 14-count brown glass bottles that have white plastic child-resistant caps. A white label affixed to the bottle has the word "Temozolomide" printed in black lettering.
The file
- Sold at
- Clinics and pharmacies nationwide as a prescribed medicine from July 2013 to August 2015. The container was included in the cost of the medication which is based on quantities prescribed, health insurance terms and other factors.
- Product type
- Tablet or Capsule Drugs
- Made in
- United States
- Recalled by
- Merck Sharp & Dohme Corp., of Whitehouse Station, N.J.
Incident log
None reported.
What the notice says to do
Consumers should immediately inspect their bottle caps for cracks. If a crack is found, consumers should contact Merck for a replacement cap. As with all drug products, the bottles should be stored up high, out of sight and reach of young children. Consumers may continue to use the drug as directed.
Merck Information Center at 800-943-8069 from 8 a.m. to 8 p.m. ET Monday through Friday, or visit www.merck.com and click on "Important Temodar Information" for more information.
Recall notice published by the U.S. Consumer Product Safety Commission. This site is independent: always confirm on the official notice before acting.
Notice first dated AUG 18 2015; last revised AUG 19 2015.
