Product Recall Number: 15-219
Why was Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules recalled?
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.
Product Recall Number: 15-219
Product Safety Warning Number:
Date: 2015-08-18
Product Safety Warning Date:
Name Of Product: Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
Description: 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.
Hazard Description: 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.
Consumer Action: None Listed
Original Product Safety Warning Announcement: None Listed
Remedy Type: Replace
Units: About 276,000
Incidents: None reported.
Remedy: 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.
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.
Importers: None Listed
Manufacturers: Merck Sharp & Dohme Corp., of Whitehouse Station, N.J.
Distributors: None Listed
Manufactured In: United States
Custom Label: None Listed
Custom Field: None Listed