Subjects: CHI, RCL
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 |
|
Zofran ODT® |
0078-0679-61 0078-0679-19 |
4 mg |
30 count: 3 |
1657088
|
Dec 2019
|
|
Zofran ODT® |
0078-0680-61 0078-0680-19 |
8 mg |
30 count: 3 |
1641546
|
Oct 2019
|
|
Entresto® (sacubitril/valsartan) |
0078-0659-61 0078-0659-35 |
24 mg/ |
100 count: 10 |
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/ |
100 count: 10 |
FX000001 F0006 F0005 F0004 |
Dec 2019 Oct 2019 Aug 2019 Oct 2018 |
|
Entresto® (sacubitril/valsartan) |
0078-0696-61 0078-0696-35 |
97 mg/ |
100 count: 10 |
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 |
Tablet |
NDC |
Carton |
|
Azithromycin Tablets |
250 mg |
0781-5776-06 0781-5776-69 |
50 count: 5 cards with |
|
Donepezil ODT |
5 mg |
0781-5276-06 0781-5276-64 |
30 count: 3 cards with |
|
Donepezil ODT |
10 mg |
0781-5277-06 0781-5277-64 |
30 count: 3 cards with |
|
Haloperidol Tablets |
0.5 mg |
0781-1391-13 |
100 count: 10 cards |
|
Haloperidol Tablets |
1 mg |
0781-1392-13 |
100 count: 10 cards |
|
Haloperidol Tablets |
2 mg |
0781-1393-13 |
100 count: 10 cards |
|
Haloperidol Tablets |
5 mg |
0781-1396-13 |
100 count: 10 cards |
|
Haloperidol Tablets |
10 mg |
0781-1397-13 |
100 count: 10 cards |
|
Imipramine HCl |
25 mg |
0781-1764-13 |
100 count: 10 cards |
|
Imipramine HCl |
50 mg |
0781-1766-13 |
100 count: 10 cards |
|
Isosorbide Dinitrate (ISDN) Tablets |
10 mg |
0781-1556-13 |
100 count: 10 cards |
|
Isosorbide Dinitrate |
20 mg |
0781-1695-13 |
100 count: 10 cards |
|
Naratriptan Tablets |
2.5 mg |
0781-5527-06 0781-5527-37 |
9 count: 1 card with 9 |
|
Ondansetron Tablets |
8 mg |
0781-1681-33 |
3 count: 1 card with 3 |
|
Ondansetron ODT |
4 mg |
0781-5238-06 0781-5238-64 |
30 count: 3 cards with |
|
Ondansetron ODT |
8 mg |
0781-5239-06 0781-5239-64 |
30 count: 3 cards with |
|
Ondansetron ODT |
8 mg |
0781-5239-06 0781-5239-80 |
10 count: 1 card with |
|
Perphenazine Tablets |
2 mg |
0781-1046-13 |
100 count: 10 cards |
|
Perphenazine Tablets |
4 mg |
0781-1047-13 |
100 count: 10 cards |
|
Perphenazine Tablets |
8 mg |
0781-1048-13 |
100 count: 10 cards |
|
Risperidone ODT |
0.5 mg |
0781-5310-06 0781-5310-08 |
28 count: 7 cards with |
|
Risperidone ODT |
1 mg |
0781-5311-06 0781-5311-08 |
28 count: 7 cards with |
|
Risperidone ODT |
2 mg |
0781-5312-06 0781-5312-08 |
28 count: 7 cards with |
|
Risperidone ODT |
3 mg |
0781-5313-06 0781-5313-08 |
28 count: 7 cards with |
|
Risperidone ODT |
4 mg |
0781-5314-06 0781-5314-08 |
28 count: 7 cards with |
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
SOURCE U.S. Consumer Product Safety Commission
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