Article Source: CPSC
-----------NEWS from CPSC-----------
U.S. Consumer Product Safety Commission
Office of Communications
4330 East West Highway, Bethesda, MD 20814
www.cpsc.gov
1. Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements: https://www.cpsc.gov/Recalls/2...
2. Camso Recalls Dirt to Snow Bike Conversion Kits Due to Crash and Impact Hazards: https://www.cpsc.gov/Recalls/2...
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1. Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements:
Recall Date: July 6, 2018
Recall Number: 18-183
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: New Instructions
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.
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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.”
Pictures available here: https://www.cpsc.gov/Recalls/2...
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 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
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.
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2. Camso Recalls Dirt to Snow Bike Conversion Kits Due to Crash and Impact Hazards
Recall Date: July 6, 2018
Recall Number: 18-184
Recall Summary
Name of Product:
Camso dirt to snow bike conversion kits
Hazard:
The bolts on the brakes can loosen, posing a crash or impact hazard.
Remedy: Repair
Consumers should immediately stop using bikes with the recalled conversion kits and contact an authorized Camso dealer for a free repair.
Consumer Contact:
Camso toll-free at 866-533-0008 from 8 a.m. to 5 p.m. ET Monday through Friday or online at www.camso.co and click on “service and support” for more information.
Pictures available here: https://www.cpsc.gov/Recalls/2...
Recall Details
Units:
About 480 (In addition, 430 were sold in Canada)
Description:
This recall involves model year 2018 Camso DTS 129 and Yeti Snow MX kits that are used to convert off road motorcycles or dirt bikes to track and ski vehicles. The DTS 129 kits have a serial number starting with 9025ICEXXXX located on the conversion system frame. The Yeti Snow MX kits have a serial number starting with YE3XXXX located under the system. DTS 129 and the Camso logo or the Yeti logo are printed on the side of the product.
Incidents/Injuries:
Camso has received two reports involving the DTS 129 brake disc bolts loosening and seven reports involving the Yeti Snow MX brake disc bolts loosening. No injuries have been reported.
Sold At:
Powersports dealers nationwide from August 2017 through May 2018 for about $4,800 for the DTS and $7,700 for the Yeti.
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Manufacturer(s):
Camso Inc. of Quebec, Canada
Importer(s):
Camso Inc. of Quebec, Canada
Manufactured In:
Canada
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The U.S. Consumer Product Safety Commission (CPSC) is still interested in receiving incident or injury reports that are either directly related to a product recall or involve a different hazard with the same product. Please tell us about your experience with the product on SaferProducts.gov.
Media Contact
Please use the phone numbers below for all media requests.
Phone: (301) 504-7908
Spanish: (301) 504-7800
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.
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