Drug recall notice for Novartis and Sandoz blister packs

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:

Zofran ODT®

Carton configuration: 30 count—3 cards with 10 tablets each
1657088
1641546

Entresto® (sacubitril/valsartan)

Carton configuration: 100 count—10 cards with 10 tablets each

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:

Azithromycin tablets

NDC numbers: 0781-5776-69, 0781-5776-06
Carton configuration: 50 count—5 cards with 10 tablets each

Donepezil ODT tablets

Carton configuration: 30 count—3 cards with 10 tablets each

Haloperidol tablets

Carton configuration: 100 count—10 cards with 10 tablets each

Imipramine Hcl tablets

Carton configuration: 100 count—10 cards with 10 tablets each

Isosorbide dinitrate (ISDN) tablets

Carton configuration: 100 count—10 cards with 10 tablets each

Naratriptan tablets

NDC numbers:  0781-5527-37, 0781-5527-06
Carton configuration: 9 count—1 card with 9 tablets each

Ondansetron tablets

NDC number: 0781-1681-33
Carton configuration: 3 count—1 card with 3 tablets each

Ondansetron ODT

Perphenazine tablets

Carton configuration: 100 count—10 cards with 10 tablets each

Risperidone ODT

Carton configuration: 28 count—7 cards with 4 tablets each

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 Sandoz website and select "Patients & Customers" then "Product Safety Notices," or at Novartis website 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.

Sources

  1. Sandoz website

  2. Novartis website

  3. Consumer Product Safety Commission website

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