Donepezil ODT 10 mg
Naratriptan 2.5 mg tablets
Ondansetron Tablets 8 mg.
Risperidone ODT 2 mg.
Zofran® ODT 4 mg.
The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.
Sandoz and Novartis toll-free at 888-669-6682 from Monday to Friday, 8:30 a.m. to 5 p.m. ET or online at www.us.sandoz.com and click on “Patients and Customers” then “Product Safety Notices,” or at www.pharma.us.novartis.com and click on banner “Novartis recalls select product blister packs.”
Recall Details
This recall involves blister packages of prescription drugs from Novartis and Sandoz. The drugs are packaged with 3 to 10 tablets per blister card.
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. The recall includes the following:
|
Recalled Novartis Prescription Drugs |
NDC Numbers |
Tablet Strength |
Carton Configuration |
Lot Numbers |
Expiration Date |
|
Zofran ODT® |
0078-0679-61 0078-0679-19 |
4 mg |
30 count: 3 cards with 10 tablets each |
1657088
|
Dec 2019
|
|
Zofran ODT® |
0078-0680-61 0078-0680-19 |
8 mg |
30 count: 3 cards with 10 tablets each |
1641546
|
Oct 2019
|
|
Entresto® (sacubitril/valsartan) |
0078-0659-61 0078-0659-35 |
24 mg/ 26 mg |
100 count: 10 cards with 10 tablets each |
FX000005 FX000004 FX000003 F0010 F0009 F0007 |
Apr 2020 Apr 2020 Sep 2019 Nov 2018 Aug 2018 Jul 2018 |
|
Entresto® (sacubitril/valsartan) |
0078-0777-61 0078-0777-35 |
49 mg/ 51 mg |
100 count: 10 cards with 10 tablets each |
FX000001 F0006 F0005 F0004 |
Dec 2019 Oct 2019 Aug 2019 Oct 2018 |
|
Entresto® (sacubitril/valsartan) |
0078-0696-61 0078-0696-35 |
97 mg/ 103 mg |
100 count: 10 cards with 10 tablets each |
FX000002 F0007 F0006 F0005 F0004 |
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:
|
Recalled Sandoz Prescription Drugs |
Tablet Strength |
NDC Numbers |
Carton Configuration |
|
Azithromycin Tablets |
250 mg |
0781-5776-06 0781-5776-69 |
50 count: 5 cards with 10 tablets each |
|
Donepezil ODT Tablets |
5 mg |
0781-5276-06 0781-5276-64 |
30 count: 3 cards with 10 tablets each |
|
Donepezil ODT Tablets |
10 mg |
0781-5277-06 0781-5277-64 |
30 count: 3 cards with 10 tablets each |
|
Haloperidol Tablets |
0.5 mg |
0781-1391-13 |
100 count: 10 cards with 10 tablets each |
|
Haloperidol Tablets |
1 mg |
0781-1392-13 |
100 count: 10 cards with 10 tablets each |
|
Haloperidol Tablets |
2 mg |
0781-1393-13 |
100 count: 10 cards with 10 tablets each |
|
Haloperidol Tablets |
5 mg |
0781-1396-13 |
100 count: 10 cards with 10 tablets each |
|
Haloperidol Tablets |
10 mg |
0781-1397-13 |
100 count: 10 cards with 10 tablets each |
|
Imipramine HCl Tablets |
25 mg |
0781-1764-13 |
100 count: 10 cards with 10 tablets each |
|
Imipramine HCl Tablets |
50 mg |
0781-1766-13 |
100 count: 10 cards with 10 tablets each |
|
Isosorbide Dinitrate (ISDN) Tablets |
10 mg |
0781-1556-13 |
100 count: 10 cards with 10 tablets each |
|
Isosorbide Dinitrate (ISDN) Tablets |
20 mg |
0781-1695-13 |
100 count: 10 cards with 10 tablets each |
|
Naratriptan Tablets |
2.5 mg |
0781-5527-06 0781-5527-37 |
9 count: 1 card with 9 tablets |
|
Ondansetron Tablets |
8 mg |
0781-1681-33 |
3 count: 1 card with 3 tablets |
|
Ondansetron ODT |
4 mg |
0781-5238-06 0781-5238-64 |
30 count: 3 cards with 10 tablets each |
|
Ondansetron ODT |
8 mg |
0781-5239-06 0781-5239-64 |
30 count: 3 cards with 10 tablets each |
|
Ondansetron ODT |
8 mg |
0781-5239-06 0781-5239-80 |
10 count: 1 card with 10 tablets |
|
Perphenazine Tablets |
2 mg |
0781-1046-13 |
100 count: 10 cards with 10 tablets each |
|
Perphenazine Tablets |
4 mg |
0781-1047-13 |
100 count: 10 cards with 10 tablets each |
|
Perphenazine Tablets |
8 mg |
0781-1048-13 |
100 count: 10 cards with 10 tablets each |
|
Risperidone ODT |
0.5 mg |
0781-5310-06 0781-5310-08 |
28 count: 7 cards with 4 tablets each |
|
Risperidone ODT |
1 mg |
0781-5311-06 0781-5311-08 |
28 count: 7 cards with 4 tablets each |
|
Risperidone ODT |
2 mg |
0781-5312-06 0781-5312-08 |
28 count: 7 cards with 4 tablets each |
|
Risperidone ODT |
3 mg |
0781-5313-06 0781-5313-08 |
28 count: 7 cards with 4 tablets each |
|
Risperidone ODT |
4 mg |
0781-5314-06 0781-5314-08 |
28 count: 7 cards with 4 tablets each |
Consumers 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.
The firms have received one report of a child ingesting haloperidol from a blister pack.
Clinics and pharmacies nationwide as a prescribed medicine from September 2016 to June 2018, at prices varying based on quantities prescribed, health insurance terms and other factors.
Sandoz Inc., of Princeton, N.J. and Novartis Pharmaceuticals Corp., of East Hanover, N.J.
Related Recalls
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products under the agency’s jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical or mechanical hazard. CPSC's work to help ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters and household chemicals -– contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years.
Federal law bars any person from selling products subject to a publicly-announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission.
To report a dangerous product or a product-related injury go online to www.SaferProducts.gov or call CPSC's Hotline at 800-638-2772 or teletypewriter at 301-595-7054 for the hearing impaired. Consumers can obtain news release and recall information at www.cpsc.gov, on Twitter @USCPSC or by subscribing to CPSC's free e-mail newsletters.
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