Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements

Name of product:

Blister packages of prescription medication

Hazard:

The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.

Remedy:

New Instructions

Recall date:

July 6, 2018

Units:

About 470,000

Consumer Contact:

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

Description:

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

Remedy:

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.

Incidents/Injuries:

The firms have received one report of a child ingesting haloperidol from a blister pack.

Sold At:

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.

Distributor(s):

Sandoz Inc., of Princeton, N.J. and Novartis Pharmaceuticals Corp., of East Hanover, N.J.

Manufactured In:

Croatia, India, Ireland, Israel, Italy, Singapore, Spain, UK and U.S.

Recall number:

18-183

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