Healthcare Industry News: HSMN NewsFeed

Biopharmaceuticals Product Recall

 News Release - July 10, 2018

Sandoz Inc. and its affiliate, Novartis Pharmaceuticals Corporation, voluntarily recall select blister packages of products in the U.S. due to packaging requirements for child resistance

Voluntary recall and notice of corrective action issued after discovering certain blister card packages distributed in the U.S. do not meet U.S. child-resistant packaging requirements - Certain lots of Risperidone ODT, Donepezil ODT, Naratriptan, Ondansetron ODT, Ondansetron tablets, and Zofran ODT® (ondansetron) in blister card packages are recalled, as well as certain lots of products in Hospital Unit Dose blister packaging that may have reached consumers, including Azithromycin, Haloperidol, Imipramine, ISDN (isosorbide dinitrate), Perphenazine and Entresto® (sacubitril/valsartan) - 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

PRINCETON, N.J., July 6, 2018 -- (Healthcare Sales & Marketing Network) -- Sandoz Inc. (Sandoz) and its affiliate, Novartis Pharmaceuticals Corporation (Novartis), today announced a voluntary recall and corrective action notice for certain lots of product distributed in the U.S. in pre-packaged blister card packages (blister packs) after learning that these blister packs do not meet federal standards for child-resistant packaging, posing a risk of harm if the tablets are swallowed by children.

At Sandoz and Novartis, we take our responsibility for consumer safety very seriously. As soon as we became aware of the issue, we immediately notified the U.S. Consumer Product Safety Commission (CPSC) and Food and Drug Administration (FDA) that the blister packs at issue 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 Novartis at 1-888-NOW NOVA or 1-888-669-6682 for instructions. Products in bottles are NOT impacted by this recall.

Sandoz Products

The products affected by the recall and corrective action notice include production lots of the following medicines in blister packs that have been distributed by Sandoz in the U.S. to date:

Azithromycin: 250mg tablets in 50 count hospital unit dose blister packages. The only affected National Drug Code (NDC) number for cartons is: #0781-5776-69. The only affected NDC number for blister pack is: #0781-5776-06. This recall does NOT include Azithromycin 250mg 6 tablet or 500mg 3 tablet blister packs or any product dispensed by pharmacists in bottles.

Donepezil ODT: 5mg and 10mg in 30 count unit dose blister packs. The affected NDC numbers on cartons are: #0781-5276-64 and #0781-5277-64. The affected NDC numbers for blister packs are: #0781-5276-06 and #0781-5277-06.

Haloperidol: 0.5mg, 1mg, 2mg, 5mg and 10mg in 100 count hospital unit dose blister packages. The affected NDC numbers are: #0781-1391-13, #0781-1392-13, #0781-1393-13, #0781-1396-13 and #0781-1397-13. This recall does NOT include any product dispensed by pharmacists in bottles.

Imipramine: 25mg and 50mg in 100 count hospital unit dose blister packages. The affected NDC numbers are #0781-1764-13 and #0781-1766-13. This recall does NOT include any product dispensed by pharmacists in bottles.

ISDN (Isosorbide dinitrate): 10mg and 20mg in 100 count hospital unit dose blister packages. The affected NDC numbers are #0781-1556-13 and #0781-1695-13. This recall does NOT include any product dispensed by pharmacists in bottles.

Naratriptan: 2.5mg in 9 count unit dose blister packs. The affected NDC number for carton is: #0781-5527-37. The affected NDC number for blister pack is: #0781-5527-06.

Ondansetron ODT: 4mg and 8mg Orally Disintegrating Tablets (ODT) in blister packs. The affected NDC numbers for cartons are: #0781-5238-64, #0781-5239-80 and #0781-5239-64. The affected NDC numbers for blister packs are: #0781-5238-06 and #0781-5239-06.

Ondansetron: 8mg tablets in blister packs of 3 tablets. The only affected NDC number is #0781-1681-33. This recall does NOT include Ondansetron 4mg tablets in unit dose blister packs of 3 tablets or Ondansetron tablets dispensed by pharmacists in bottles.

Perphenazine: 2mg, 4mg and 8mg in 100 count hospital unit dose blister packages. The affected NDC numbers are #0781-1046-13, #0781-1047-13 and #0781-1048-13. This recall does NOT include any product dispensed by pharmacists in bottles.

Risperidone ODT: 0.5mg, 1mg, 2mg, 3mg and 4mg Orally Disintegrating Tablets (ODT) in 28 count blister packs. The affected NDC numbers for cartons are: #0781-5310-08, #0781-5311-08, #0781-5312-08, #0781-5313-08, and #0781-5314-08. The affected NDC numbers for blister packs are: #0781-5310-06, #0781-5311-06, #0781-5312-06, #0781-5313-06 and #0781-5314-06.

Consumers or pharmacies who have impacted blister packs with these NDC numbers in their homes or pharmacies should contact Novartis at 1-888-NOW NOVA or 1-888-669-6682 for important instructions on corrective actions. A complete list of the affected lot numbers with expiry dates and package photos is available at https://www.us.sandoz.com/patients-customers/product-safety-notices

Novartis Products

The products affected by the recall and corrective action notice include production lots of the following medicines in blister packs that have been distributed by Novartis in the U.S. to date:

Entresto® (sacubitril/valsartan) tablets: 24mg/26mg, 49mg/51mg and 97mg/103mg in 100 count tablet hospital unit dose blister packages. The affected NDC numbers for cartons are #0078-0659-35, #0078-0777-35 and #0078-0696-35. The affected NDC numbers for blister packs are #0078-0659-61, #0078-0777-61, and #0078-0696-61. This recall and corrective action notice does NOT include tablets dispensed by pharmacists in bottles.

Zofran® ODT (ondansetron): 4mg and 8mg Orally Disintegrating Tablets (ODT) in blister packs. The affected NDC numbers for cartons are: #0078-0679-19 and #0078-0680-19. The affected NDC numbers for blister packs are: #0078-0679-61 and #0078-0680-61.

A complete list of the affected lot numbers with expiry dates and package photos is available at

https://www.pharma.us.novartis.com/recall-zofran-and-entresto-packages

Consumers or pharmacies who have impacted blister packs with these NDC numbers in their homes or pharmacies should contact Novartis at 1-888-NOW NOVA or 1-888-669-6682 for important instructions on corrective actions. For more information on Novartis products, please find details on our website: https://www.pharma.us.novartis.com/.

About Sandoz

Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people's lives. We contribute to society's ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.

Sandoz is on Twitter. Sign up to follow @Sandoz_global at http://twitter.com/Sandoz_Global.

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About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 124,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.


Source: Novartis

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