Zofran and Entresto Recall Packages

Beware of kids getting into Zofran (Ondansetron), Risperidone, onepezil ODT, Naratriptan, or Entresto (sacubitril / valsartan) drug packages.

Two drug companies, Sandoz and Novartis, recall their prescription drug packages because they do not satisfy child-resistant closure requirements

The United States Consumer Protection Safety Commission “is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency’s jurisdiction.” On July 6, 2018, it announced a blister package of prescription medication.

Federal law – the Poison Prevention Packaging Act of 1970 (15 U.S.C. § 1471 et seq.) – requires drug companies to make packaging that prevents children from being able to take the medications. In this case, the blister packages, which look like these images from the CPSC, were not. “Products in bottles are NOT impacted,” only these kinds of packages:

As reported by CPSC, this recall applies to 470,000 packages on the marketing. These drugs were distributed at clinics and pharmacies across the country from September 2016 to June 2018. The recalled Novartis prescription blister packages have “Novartis,” the name of the drug, dosage, NDC, lot number and expiration date printed on the cartons and the blister cards.

Importantly, please note that “This action is not a result of any quality or safety concerns with the medications for their intended use.” In other words, this does not have to do with patients using the drug as prescribed to them by a licensed healthcare professional in accordance with the instructions provided. While plaintiffs have sued the makers of Zofran for allegedly causing birth defects, this particular recall has nothing to do with patients prescribed the drug by a licensed medical professional.

Nevertheless, this is a safety issue. “The blister cards in which these products are packaged are not child-resistant, posing a risk of harm if the tablets are swallowed by children.” Children may be poisoned if they get into these Zofran or Entresto packages. At least one child has already gotten into the drugs.

This is the safety notice from Sandoz for Risperidone:

What to do

If you have one of the drugs listed below, you “should immediately secure the blister cards to keep them out of the sight and reach of children and contact Novartis or Sandoz for further instructions. Novartis and Sandoz advise that consumers should continue to use the medication as directed once the blister packages are secured.”

Novartis directs consumers to call “888-NOW-NOVA (888-669-6682) from 8 a.m. to 8 p.m. ET Monday through Friday and 9 a.m. to 6 p.m. ET Saturday and Sunday to order a child-resistant pouch in which to store the blister packs within your possession.”

What to look for

Novartis provides the following representative phots:

“These images show the type of packaging involved in the voluntary recall. Products in bottles are NOT impacted. NDC numbers, lot numbers and expiration dates in the following example images should be disregarded. They are NOT those involved in the recall. Please refer to the table of affected lots above.”

Novartis identifies the following packages:

Novartis Pharmaceuticals Corporation (“Novartis”), in cooperation with the U.S. Consumer Product Safety Commission (“CPSC”) and Food and Drug Administration (“FDA”), is voluntarily implementing a CPSC-approved corrective action plan for the following product packages distributed in the United States. This action is not a result of any quality or safety concerns with the medications for their intended use.

The blister cards in which these products are packaged are not child-resistant, posing a risk of harm if the tablets are swallowed by children. Products in bottles are NOT impacted.

Zofran ODT® 4mg and 8mg (ondansetron) Orally Disintegrating Tablets (ODT)

This notification applies ONLY to the NDCs and lot numbers below:

Product Description: Zofran ODT 4 mg
Package Description: Blister packs of 30 tablets
NDC Number on Carton: 0078-0679-19
NDC Number on Blister Pack: 0078-0679-61
Lot Number: 1657088
Expiration Date: Dec 2019

Product Description: Zofran ODT 8 mg
Package Description: Blister packs of 30 tablets
NDC Number on Carton: 0078-0680-19
NDC Number on Blister Pack: 0078-0680-61
Lot Number: 1641546
Expiration Date: Oct 2019

ENTRESTO® (sacubitril / valsartan) Tablets in 100 Count Hospital Unit Dose Blister Packages

This notification applies ONLY to the NDCs and lot numbers below:

Product Description: Entresto FCT 24mg/26mg HUD
NDC Number on Carton: 0078-0659-35
NDC Number on Blister Card: 0078-0659-61
Lot Numbers: FX000005, FX000004, FX000003, F0010, F0009, F0007
Expiration Dates: Apr 2020, Apr 2020, Sep 2019, Nov 2018, Aug 2018, Jul 2018

Product Description: Entresto FCT 49mg/51mg HUD
NDC Number on Carton: 0078-0777-35
NDC Number on Blister Card: 0078-0777-61
Lot Numbers: FX000001, F0006, F0005, F0004
Expiration Dates: Dec 2019, Oct 2019, Aug 2019, Oct 2018

Product Description: Entresto FCT 97mg/103mg HUD
NDC Number on Carton: 0078-0696-35
NDC Number on Blister Card: 0078-0696-61
Lot Numbers: FX000002, F0007, F0006, F0005, F0004
Expiration Dates: Mar 2020, Feb 2020, Dec 2019, Dec 2018, Oct 2018

CPSC reports that the recall includes the following:

Zofran ODT®
NDC Numbers: 0078-0679-61, 0078-0679-19
Tablet Strength: 4 mg
Carton Configuration: 30 count: 3 cards with 10 tablets each
Lot Numbers: 1657088
Expiration Date: Dec 2019

Zofran ODT®
NDC Numbers: 0078-0680-61, 0078-0680-19
Tablet Strength: 8 mg
Carton Configuration: 30 count: 3 cards with 10 tablets each
Lot Numbers: 1641546
Expiration Date: Oct 2019

Entresto® (sacubitril/valsartan)
NDC Numbers: 0078-0659-61, 0078-0659-35
Carton Configuration: 24 mg/ 26 mg 100 count: 10 cards with 10 tablets each
Lot Numbers: FX000005, FX000004, FX000003, F0010, F0009, F0007
Expiration Date: Apr 2020, Apr 2020, Sep 2019, Nov 2018, Aug 2018, Jul 2018

Entresto® (sacubitril/valsartan)
NDC Numbers: 0078-0777-61, 0078-0777-35
Carton Configuration: 49 mg/ 51 mg 100 count: 10 cards with 10 tablets each
Lot Numbers: FX000001, F0006, F0005, F0004
Expiration Date: Dec 2019, Oct 2019, Aug 2019, Oct 2018

Entresto® (sacubitril/valsartan)0078-0696-61
NDC Numbers: 0078-0696-35
Carton Configuration: 97 mg/ 103 mg 100 count: 10 cards with 10 tablets each
Lot Numbers: FX000002, F0007, F0006, F0005, F0004
Expiration Date: Mar 2020, Feb 2020, Dec 2019, Dec 2018, Oct 2018

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.

Lot numbers are listed at www.us.sandoz.com/patients-customers/product-safety-notices.

The recall includes the following:

Azithromycin Tablets
Tablet Strength: 250 mg
NDC Numbers: 0781-5776-06, 0781-5776-69
Carton Configuration: 50 count: 5 cards with 10 tablets each

Donepezil ODT Tablets
Tablet Strength: 5 mg
NDC Numbers: 0781-5276-06, 0781-5276-64
Carton Configuration: 30 count: 3 cards with 10 tablets each

Donepezil ODT Tablets
Tablet Strength: 10 mg
NDC Numbers: 0781-5277-06, 0781-5277-64
Carton Configuration: 30 count: 3 cards with 10 tablets each

Haloperidol Tablets
Tablet Strength: 0.5 mg
NDC Numbers: 0781-1391-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Haloperidol Tablets
Tablet Strength: 1 mg
NDC Numbers: 0781-1392-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Haloperidol Tablets
Tablet Strength: 2 mg
NDC Numbers: 0781-1393-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Haloperidol Tablets
Tablet Strength: 5 mg
NDC Numbers: 0781-1396-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Haloperidol Tablets
Tablet Strength: 10 mg
NDC Numbers: 0781-1397-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Imipramine HCl Tablets
Tablet Strength: 25 mg
NDC Numbers: 0781-1764-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Imipramine HCl Tablets
Tablet Strength: 50 mg
NDC Numbers: 0781-1766-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Isosorbide Dinitrate (ISDN) Tablets
Tablet Strength: 10 mg
NDC Numbers: 0781-1556-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Isosorbide Dinitrate (ISDN) Tablets
Tablet Strength: 20 mg
NDC Numbers: 0781-1695-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Naratriptan Tablets
Tablet Strength: 2.5 mg
NDC Numbers: 0781-5527-06, 0781-5527-37
Carton Configuration: 9 count: 1 card with 9 tablets

Ondansetron Tablets
Tablet Strength: 8 mg
NDC Numbers: 0781-1681-33
Carton Configuration: 3 count: 1 card with 3 tablets

Ondansetron ODT
Tablet Strength: 4 mg
NDC Numbers: 0781-5238-06, 0781-5238-64
Carton Configuration: 30 count: 3 cards with 10 tablets each

Ondansetron ODT
Tablet Strength: 8 mg
NDC Numbers: 0781-5239-06, 0781-5239-64
Carton Configuration: 30 count: 3 cards with 10 tablets each

Ondansetron ODT
Tablet Strength: 8 mg
NDC Numbers: 0781-5239-06, 0781-5239-80
Carton Configuration: 10 count: 1 card with 10 tablets

Perphenazine Tablets
Tablet Strength: 2 mg
NDC Numbers: 0781-1046-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Perphenazine Tablets
Tablet Strength: 4 mg
NDC Numbers: 0781-1047-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Perphenazine Tablets
Tablet Strength: 8 mg
NDC Numbers: 0781-1048-13
Carton Configuration: 100 count: 10 cards with 10 tablets each

Risperidone ODT
Tablet Strength: 0.5 mg
NDC Numbers: 0781-5310-06, 0781-5310-08
Carton Configuration: 28 count: 7 cards with 4 tablets each

Risperidone ODT
Tablet Strength: 1 mg
NDC Numbers: 0781-5311-06, 0781-5311-08
Carton Configuration: 28 count: 7 cards with 4 tablets each

Risperidone ODT
Tablet Strength: 2 mg
NDC Numbers: 0781-5312-06, 0781-5312-08
Carton Configuration: 28 count: 7 cards with 4 tablets each

Risperidone ODT
Tablet Strength: 3 mg
NDC Numbers: 0781-5313-06, 0781-5313-08
Carton Configuration: 28 count: 7 cards with 4 tablets each

Risperidone ODT
Tablet Strength: 4 mg
NDC Numbers: 0781-5314-06, 0781-5314-08
Carton Configuration: 28 count: 7 cards with 4 tablets each