Product Safety Notices

Dec 01, 2021

Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion during Shipping

Company Contact:
Leslie Pott
201-354-0279

FOR IMMEDIATE RELEASE – December 1, 2021 – Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injection Lot SAB06761A was shipped to customers in the months of September and October 2021.

The exposure to higher temperatures may have significantly impacted the recalled  product’s (lot SAB06761A) effectiveness and thus there may be reasonable probability of risk for patients with  health conditions that the product is intended to treat.  Such patients could be at risk for  blood clots blocking  blood vessels, an artery, or traveling to other tissues or organs causing pain, swelling, stroke, clots to the lung or death as a result of the underlying condition.   To date, Sandoz has not received any reports of adverse events or injuries related to this recall.

The product is used for prevention of deep vein thrombosis (DVT) a condition that occurs when a blood clot forms in a deep vein, usually in the legs that can occur after surgeries or in patients with restricted mobility during illness; or prevention of complications associated with heart attacks. The product is packaged in cartons containing ten 0.4 mL syringes, NDC 0781-3246-64.  Enoxaparin Sodium Injection was distributed Nationwide in the USA to wholesalers and retailers. 

Product Name NDC Number Lot Number Expiration Date Date of Manufacture
Enoxaparin Sodium Injection, USP 40 mg/0.4 mL 00781-3246-64 SAB06761A 04/2023 05/26/2021

Please note: this recall is specific to only one batch (SAB06761A) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL and does not apply to any other strengths of Sandoz Enoxaparin Sodium Injection, USP or to other lots of the 40 mg/0.4 mL SKU. Any product returned that is not associated with this recall will be destroyed and no credit issued.


Consumers who have Enoxaparin Sodium Injection, USP 40 mg/0.4 mL (NDC 00781-3246-64 and Lot number SAB06761A) which is being recalled, should stop taking the recalled product, immediately consult with their physician to attain another prescription, and return the product where originally purchased. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Sandoz has already notified its wholesalers and retailers by mail and is arranging for return of all recalled product.

Pharmacists should contact Sedgwick directly by phone at 844-265-7389 or by email at [email protected] to request a recall packet. Representatives are available Monday – Friday, 8:00 am – 5:00 pm ET.

In case of any adverse reactions, please call Sandoz at (800) 525-8747 or email [email protected].  Customer service agents are available Monday – Friday from 8:30 am to 5:00 pm ET. Adverse events can also be reported to FDA online at www.fda.gov/medwatch/report.htm.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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*Enoxaparin sodium injection is a product of Sandoz, Inc.

INDICATION AND IMPORTANT SAFETY INFORMATION 

Please see full Prescribing Information for additional safety information. 

Disclaimer 

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potentially,” “can,” “will,” “may,” “could,” “initiating,” or similar terms, or by express or implied discussions regarding the potential outcome of the nationwide recall of Enoxaparin Sodium Injection 40MG Lot #SAB06761A, or regarding potential future revenues from such product. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee as to the outcome of the nationwide recall of Enoxaparin Sodium Injection 40MG Lot #SAB06761A. In particular, our expectations regarding such product could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such product; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 

About Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.

 

Sandoz on social media
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# # #

Novartis Media Relations

E-mail: [email protected]

Julie Masow

Novartis US Communications

+1 862 579 8456 (mobile)

[email protected]

 

Leslie Pott
Sandoz US Communications
+1 201 354 0279 (mobile)

[email protected]

 

Novartis Investor Relations

Central Investor relations line: +41 61 324 7944

E-mail: [email protected]

 

North America

  

Sloan Simpson

+1 862 778 5052

Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product

 

Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall.

 

 

PHARMACY ACTION:

Pharmacists are being requested to contact Stericycle directly 1-888-667-1497 Monday – Friday 8:00am – 5:00pm EST to request a recall packet.

Patients are asked to continue taking their medication and speak to their physician on alternative healthcare treatment options. Per U.S. Food and Drug Administration guidance, consumers are asked to continue taking their medication until they speak to their physician or pharmacist on alternate healthcare treatment options.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.   Consumers with questions regarding this recall can contact Sandoz at 1-800-525-8747 option # between 8:30am – 5:00pm Monday – Friday EST or www.us.sandoz.com for more information.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine Hydrochloride Capsules is an oral product, indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable. The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label. 

The product can be identified by the NDC Numbers and Lot Numbers Listed Here >>

Sandoz will be notifying its distributors and customers via overnight mail and via the Sandoz web site, and will arrange for return of all recalled products. Wholesalers (direct customers) will be asked to immediately stop distribution and return any stock to Sandoz, and contact the retail pharmacies in their group to do the same.  Pharmacies will be asked to immediately stop dispensing Sandoz Ranitidine Hydrochloride Capsules and return remaining stock to Sandoz by contacting Stericycle to request a recall packet. Consumers are asked to continue taking their medication and speak to their physician or pharmacist on alternate healthcare treatment options.

Consumers with questions regarding this recall can contact Sandoz at 1-800-525-8747 option # between 8:30am – 5:00pm Monday – Friday EST or www.us.sandoz.com for more information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. 

 

 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration

 

 

Sandoz Inc. voluntarily recalls Losartan Potassium and Ezetimibe in prescription drug bottles in the U.S. due to failure to meet child-resistant closure requirements

 

  • Voluntary recall and notice of corrective action issued because the cap and bottle combination for two medicines distributed in capped bottles in the U.S. does not meet U.S. child-resistant packaging requirements
  • Particular lots of Ezetimibe 10 mg Tablets and Losartan Potassium 50 mg Tablets packaged in prescription drug bottles are recalled
  • There are no quality or safety issues with the medicines for their intended use. Patients should immediately secure bottled medicines and their contents to keep out of the sight and reach of children
  • Patients should continue to use the medicine as prescribed and call 1-800-525-8747 option # to receive free replacement child-resistant bottle caps.   

At Sandoz, 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 cap and bottle combination at issue is not compliant for consumer home use.  As a result, we are voluntarily recalling and implementing corrective action for these selected lots.

This action is only necessary because the cap and bottle combination does not meet federal standards for child-resistant packaging.  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 bottled medicines so that they are out of the sight and reach of children, and contact Sandoz at 1-800-525-8747 option # or www.us.sandoz.com for more information and free replacement child-resistant bottle caps.

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

 

Ezetimibe: 10mg tablets in 30 and 90 count bottles. National Drug Code (NDC) numbers are # 0781-5690-31 (30 tablets) and # 0781-5690-92 (90 tablets).  

 

Only particular Lot Numbers are affected. 

 

Losartan Potassium: 50mg in 30 count bottles. The affected NDC number is # 0781-5701-31.

Corrective Action

Consumers or pharmacies who have impacted prescription drug bottles with these NDC numbers should contact Sandoz at 1-800-525-8747 option # for free replacement child-resistant bottle caps.

A complete list of the affected lot numbers with expiry dates and package photos is available on the Safety Poster below: 

See Safety Notice poster for more information, including Lot Numbers.

 

 


Important Correction of Drug Information

Notice to Healthcare Professionals Regarding Sandoz's Bivalirudin for Injection, 250mg/vial   

Click here to read 

 

 

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

See Products affected below:

               PDF icon  Risperidone Safety Notice Poster 

               PDF iconAdditional Products Safety Notice Poster

               PDF icon  Ondansetron Safety Notice poster

 

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 (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.

 

Corrective Action

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 1-888-NOVA-NOW to request your pouch.

 

 

Here are some easy instructions on how to use your child-resistant, re-sealable pouch.



 

 

 

Sandoz Products

 

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.

PDF iconAzithromycin NDC numbers and Lot numbers
This recall does NOT include Azithromycin 250 mg 6 tablet or 500 mg 3 tablet blister packages, or any product dispensed by pharmacists in bottles.

Donepezil ODT: 5 mg and 10 mg in 30 count hospital unit dose blister packages.

PDF icon Donepezil NDC numbers and Lot numbers
This does not include any product dispensed by pharmacists in bottles

Haloperidol: 0.5mg, 1mg, 2mg, 5mg and 10mg in 100 count hospital unit dose blister packages.

    

PDF iconHaloperidol NDC numbers and Lot numbers
This recall does not include any product dispensed by pharmacists in bottles.

Imipramine: 25mg and 50mg in 100 count hospital unit dose blister packages.

   

PDF iconImipramine NDC numbers and Lot numbers

This recall does not include any product dispensed by pharmacists in bottles.

 

Isosorbide Dinitrate (ISDN): 10mg and 20mg in 100 count hospital unit dose blister packages.

 

PDF iconIsosorbide Dinitrate (ISDN) NDC numbers and Lot numbers
This recall does not include any product dispensed by pharmacists in bottles.

 

Naratriptan Tablets: 2.5 mg in 9 count hospital unit dose blister packages.

PDF iconNaratriptan NDC numbers and Lot numbers
This recall does not include any product dispensed by pharmacists in bottles.

 

Ondansetron ODT: 4mg and 8mg Orally Disintegrating Tablets (ODT).

PDF icon Ondansetron ODT NDC numbers and Lot numbers
This recall does not include any product dispensed by pharmacists in bottles.

 

Ondansetron: 8mg tablets in blister packs of 3 tablets. 

PDF icon Ondansetron Tablets NDC numbers and Lot numbers
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: 2 mg, 4 mg and 8 mg in 100 count hospital unit dose blister packages.

   

PDF iconPerphenazine NDC numbers and Lot numbers
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 packages.

PDF icon Risperidone NDC numbers and Lot numbers
This recall does not include any product dispensed by pharmacists in bottles.

Consumers or pharmacies who have impacted blister packaged products with these NDC numbers in their homes or pharmacies should contact us at 1-888-NOW-NOVA or 1-888-669-6682.  

 

 

 

 

 

 

 

 

Sandoz DHCP-Bivalirudin for Injection leaflet error (PDF 494.23 KB)

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