We want to alert you to a recall of Novartis® and Sandoz® blister packs, effective July 5, 2018. We recommend you review your patients' medical records and contact all patients for whom you have prescribed these medications to warn them of the possible problem.
Novartis and Sandoz Inc. voluntarily recalled the medications after discovering that certain blister-card packages distributed in the U.S. do not meet U.S. child-resistant packaging requirements and are not compliant for consumer home use.
This recall is due to the in-home dispensing of some hospital-unit-dose blister packs intended for institutional use. As a result, Novartis and Sandoz have implemented a corrective action plan at the consumer level for packaging that does not meet U.S. child-resistant packaging requirements. The packaging is not child-resistant, posing a risk of harm if the tablets are swallowed by children.
Recalled Novartis prescription drugs
The recalled Novartis prescription blister packages have “Novartis,” the name of the drug, dosage, National Drug Code (NDC), lot number and expiration date printed on the carton and the blister cards. The recall includes the following:
Recalled Sandoz prescription drugs
The recalled Sandoz prescription blister packages have “Sandoz,” the name of the drug, dosage, NDC and lot number printed on the cartons and the blister cards. The recall includes the following:
Information for your patients
To secure medications in blister packs in the homes of consumers, Sandoz will provide child-resistant resealable pouches to store the medication.
Patients should immediately secure impacted blister-card packages and the contents to keep out of the sight and reach of children.
Patients should continue to use the medicine as prescribed and call Sandoz for important information on corrective action and to request a secure pouch.
Consumer contact information provided by Sandoz: Call toll-free at 1-888-669-6682, from Monday to Friday, 8 a.m. to 8 p.m., and Saturday and Sunday, 9 a.m. to 6 p.m., Eastern time. Or visit online at , opens new window and select "Patients & Customers" then "Product Safety Notices," or at , opens new window and select the banner "Novartis recalls select product blister packs."
Products dispensed in bottles are not impacted by this recall.
There are no quality or safety issues with the medications for their intended use.