The Recall Desk
HighCPSC·15219·Announced 2015-08-18

Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps

Merck is recalling approximately 276,000 bottles of Temodar and Temozolomide capsules because cracked caps may fail to keep young children from accessing the medication.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (chemotherapy medication accessible to children) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Merck Sharp & Dohme Corp. is recalling approximately 276,000 bottles of Temodar (Temozolomide) and Temozolomide (generic) capsules. The recall involves 5- and 14-count brown glass bottles with white plastic child-resistant caps that may have cracks. These oral chemotherapy drugs were distributed to clinics and pharmacies nationwide as prescribed medicines from July 2013 to August 2015.

The cracked caps may render the child-resistant closure ineffective, allowing young children to gain unintended access to the capsules. This poses a risk of poisoning. No injuries have been reported in connection with this recall.

Consumers should immediately inspect their bottle caps for cracks. If a crack is found, they should contact Merck for a replacement cap. As with all drug products, bottles should be stored up high, out of sight and reach of young children. Consumers may continue to use the drug as directed. For more information, consumers can contact the Merck Information Center at 800-943-8069 from 8 a.m. to 8 p.m. ET Monday through Friday, or visit www.merck.com.

The recalled product

Product
Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
Manufacturer
Merck Sharp & Dohme Corp., of Whitehouse Station, N.J.
Category
Drug — Chemotherapy
Hazard
Affected units
276,000

Distribution

Distributed nationwide across the United States.

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