Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements
CPSC recall 18183. Recall date: .
Hazard, in the words of CPSC
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, in the words of CPSC
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.
CPSC recall 18183 has the recall date 6 Jul 2018. The notice names the firm Sandoz. The recall has about 470,000 units. The median CPSC recall of 2018 has 7,200 units. This register puts the recall under the hazard Poisoning.
Federal law prohibits any person from selling products subject to a Commission ordered recall or a voluntary recall undertaken in consultation with the CPSC.
CPSC publishes these words. Source: CPSC recall notices, section About the U.S. CPSC, read on . The hazard, the remedy and the incident text on this site are the words of the CPSC recall notice. Newest CPSC recall on the register: .
More of the notice
The hazard and the remedy are at the top of the page. Each quotation is the text of CPSC.
| Incidents and injuries | The firms have received one report of a child ingesting haloperidol from a blister pack. |
|---|---|
| Units | 470,000 |
| Remedy options | New Instructions |
| 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… |
| Product | Blister packages of prescription medication, About 470,000 |
| 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; Novartis Pharmaceuticals Corp |
| Made in | Croatia, India, Ireland, Israel, Italy, Singapore, Spain, United Kingdom, United States |
Recall notice: The page that CPSC publishes for one recall of a consumer product. It states the product, the hazard, the remedy and the incidents.
Hazard: The way a product can cause harm, in the words of the CPSC recall notice. This site also puts each recall under short hazard names.
Remedy: What the manufacturer or the firm does about a recalled product. The agency record states the remedy of each recall.
Units: The number of vehicles or products that a recall can include. The manufacturer or the firm reports the number to the agency.
The recall in context
- Units in this recall
- 470,000Median of 2018: 7,200
- CPSC recalls of 2018
- 258
- Recalls of 2018 with one of the same hazards
- 6%
- Recalls on the register that name Sandoz
- 2
Other recalls of the firm
| Date | Recall |
|---|---|
| 29 Aug 2019 | Sandoz Recalls Losartan Potassium and Ezetimibe Prescription Drug Bottles Due to Failure to Meet Child-Resistant Closure Requirements |
Official channels
- CPSC recall notice 18183The notice on the CPSC site, with the pictures and the contact of the firm.
- CPSC recallsThe list of all recall notices on the CPSC site.
- SaferProducts.govThe CPSC site for a report about a consumer product.
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Cite this page
Recall Register. CPSC recall 18183. https://recallregister.com/product/8353-sandoz-and-novartis-recall-prescription-drug-blister-packages-due-to-f/. Source: CPSC Recall Retrieval Web Services. Data through .
Sources
- Source
- US Consumer Product Safety Commission
- Licence
- US government work, public domain
- Data retrieved
- 30 Sep 2026
- Newest CPSC recall on the register
- 24 Sep 2026
The CPSC notice is the authority. The hazard names come from the hazard text of CPSC. The category is the product type that CPSC gives. How the register is made. Report an error.
Questions
- Does CPSC recall 18183 report injuries?
- The CPSC notice says:
The firms have received one report of a child ingesting haloperidol from a blister pack.
- Where was the product sold?
- The CPSC notice says:
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.
- Which remedy options does CPSC list for recall 18183?
- CPSC lists 1 remedy option:
New Instructions
- How many units are in CPSC recall 18183?
- The CPSC notice gives this number:
About 470,000