Sandoz recall of select blister packages of products in the U.S. due to packaging requirements for child resistance. Corrective action on packaging required.
Sandoz Inc has implemented a voluntary recall and notice of corrective action after discovering certain blister card packages distributed in the U.S. do not meet U.S. child-resistant packaging requirements, posing a risk of harm if the tablets are swallowed by children
Products dispensed in bottles are NOT impacted by this recall
There are no quality or safety issues with the medicines for their intended use
Patients should immediately secure impacted blister card packages and their contents to keep out of the sight and reach of children
Patients should continue to use the medicine as prescribed and call 1-888-NOW NOVA (1-888-669-6682) for important information on corrective actions
At Sandoz, we take our responsibility for consumer safety very seriously. The U.S. Consumer Product Safety Commission (CPSC) and Food and Drug Administration (FDA) have been notified that the blister packs for products listed below are not compliant for consumer home use. As a result, we are voluntarily recalling and implementing corrective action for these selected blister packs.
This action is only necessary because the blister packs are not child-resistant. There are no quality or safety issues with the medicines for their intended use.
Patients should continue taking their medicine as directed by their physician, secure the affected blister packs so that they are out of the sight and reach of children, and contact Sandoz at 1-888-NOW NOVA or 1-888-669-6682 for instructions. Products in bottles are NOT impacted by this recall.
To learn more about the Novartis products affected by this recall and requiring corrective action, please click here to be re-directed to the Novartis website.
All blister pack configurations (listed below) that are identified as not child-resistant and potentially dispensed for in-home use require corrective action. To secure medicines in blister packs in the homes of consumers, Sandoz will provide child-resistant re-sealable pouches to store your medication. Consumers should immediately secure your blister packs out of the sight and reach of children, and contact us at 888-NOW-NOVA or 888-669-6682 to request your pouch.
Here are some easy instructions on how to use your child-resistant, re-sealable pouch.
The products affected by the recall include production lots of the following medicines that have been distributed by Sandoz to date:
Azithromycin: 250mg tablets in 50 count unit dose blister packages.