The packaging is not child resistant as required by law
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Sandoz Inc., of Princeton, N.J., and Novartis Pharmaceuticals Corp., of East Hanover, N.J., are recalling about 470, 000 blister packages of prescription medication.
The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.
The firms have received one report of a child ingesting haloperidol from a blister pack.
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 |
The recalled products, manufactured in Croatia, India, Ireland, Israel, Italy, Singapore, Spain, UK and U.S., were 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.
What to do
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.
Consumers may contact Sandoz and Novartis toll-free at 888-669-6682 from Monday to Friday, 8 a.m. to 8 p.m. (ET) and Saturday and Sunday, 9 a.m. to 6 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.