Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements
WASHINGTON, July 6, 2018 /PRNewswire-USNewswire/ -- https://www.cpsc.gov/Recalls/2018/Sandoz-and-Novartis-Recall-Prescription-Drug-Blister-Packages-Due-to-Failure-to-Meet-Child-Resistant-Closure-Requirements
Recall Summary
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: Instructions, Notice
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.
Consumer 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."
Recall Details
Units: About 470,000
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 NDC Tablet Carton Lot Expiration
Prescription
Drugs Numbers Strength Configuration Numbers Date
------------ ------- -------- ------------- ------- ----
Zofran ODT(R) 0078-0679-61 4 mg 30 count: 3 1657088 Dec 2019
cards with 10
0078-0679-19 tablets each
--- ------------ ------------
Zofran ODT(R) 0078-0680-61 8 mg 30 count: 3 1641546 Oct 2019
cards with 10
0078-0680-19 tablets each
--- ------------ ------------
Entresto(R)
(sacubitril/
valsartan) 0078-0659-61 24 mg/ 100 count: 10 FX000005 Apr 2020
26 mg cards with 10
0078-0659-35 tablets each FX000004 Apr 2020
FX000003 Sep 2019
F0010 Nov 2018
F0009 Aug 2018
F0007 Jul 2018
--- ----- --------
Entresto(R)
(sacubitril/
valsartan) 0078-0777-61 49 mg/ 100 count: 10 FX000001 Dec 2019
51 mg cards with 10
0078-0777-35 tablets each F0006 Oct 2019
F0005 Aug 2019
F0004 Oct 2018
--- ----- --------
Entresto(R)
(sacubitril/
valsartan) 0078-0696-61 97 mg/ 100 count: 10 FX000002 Mar 2020
103 mg cards with 10
0078-0696-35 tablets each F0007 Feb 2020
F0006 Dec 2019
F0005 Dec 2018
F0004 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 Tablet NDC Carton
Prescription Drugs Strength Numbers Configuration
------------------ -------- ------- -------------
Azithromycin Tablets 250 mg 0781-5776-06 50 count: 5 cards with
10 tablets each
0781-5776-69
--- ------------
Donepezil ODT 5 mg 0781-5276-06 30 count: 3 cards with
Tablets 10 tablets each
0781-5276-64
--- ------------
Donepezil ODT 10 mg 0781-5277-06 30 count: 3 cards with
Tablets 10 tablets each
0781-5277-64
--- ------------
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 25 mg 0781-1764-13 100 count: 10 cards
Tablets with 10 tablets each
------- --------------------
Imipramine HCl 50 mg 0781-1766-13 100 count: 10 cards
Tablets with 10 tablets each
------- --------------------
Isosorbide Dinitrate (ISDN)
Tablets 10 mg 0781-1556-13 100 count: 10 cards
with 10 tablets each
--- --------------------
Isosorbide Dinitrate 20 mg 0781-1695-13 100 count: 10 cards
(ISDN) Tablets with 10 tablets each
-------------- --------------------
Naratriptan Tablets 2.5 mg 0781-5527-06 9 count: 1 card with 9
tablets
0781-5527-37
--- ------------
Ondansetron Tablets 8 mg 0781-1681-33 3 count: 1 card with 3
tablets
--- -------
Ondansetron ODT 4 mg 0781-5238-06 30 count: 3 cards with
10 tablets each
0781-5238-64
--- ------------
Ondansetron ODT 8 mg 0781-5239-06 30 count: 3 cards with
10 tablets each
0781-5239-64
--- ------------
Ondansetron ODT 8 mg 0781-5239-06 10 count: 1 card with
10 tablets
0781-5239-80
--- ------------
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 28 count: 7 cards with
4 tablets each
0781-5310-08
--- ------------
Risperidone ODT 1 mg 0781-5311-06 28 count: 7 cards with
4 tablets each
0781-5311-08
--- ------------
Risperidone ODT 2 mg 0781-5312-06 28 count: 7 cards with
4 tablets each
0781-5312-08
--- ------------
Risperidone ODT 3 mg 0781-5313-06 28 count: 7 cards with
4 tablets each
0781-5313-08
--- ------------
Risperidone ODT 4 mg 0781-5314-06 28 count: 7 cards with
4 tablets each
0781-5314-08
--- ------------
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:
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.
CPSC Consumer Information Hotline
Contact us at this toll-free number if you have questions about a recall:
800-638-2772 (TTY 301-595-7054)
Times: 8 a.m. - 5:30 p.m. ET; Messages can be left anytime
Call to get product safety and other agency information and to report unsafe products.
Media Contact
Please use the phone numbers below for all media requests.
Phone: 301-504-7908
Spanish: 301-504-7800
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SOURCE U.S. Consumer Product Safety Commission
