Blister packages of prescription medication
CPSC Recall #18-183 — July 6, 2018
Recall Summary
| Recall Number | 18-183 |
| Recall Date | July 6, 2018 |
| Remedy Type | New Instructions |
| Units Affected | About 470,000 |
| Manufactured In | Croatia, India, Ireland, Israel, Italy, Singapore, Spain, UK and U.S. |
Where It Was Sold
| 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. |
Product
Blister packages of prescription medication
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 DrugsNDC NumbersTablet StrengthCarton ConfigurationLot NumbersExpiration DateZofran ODT®0078-0679-610078-0679-194 mg30 count: 3 cards with 10 tablets each1657088 Dec 2019 Zofran ODT®0078-0680-610078-0680-198 mg30 count: 3 cards with 10 tablets each1641546 Oct 2019 Entresto® (sacubitril/valsartan)0078-0659-610078-0659-3524 mg/ 26 mg100 count: 10 cards with 10 tablets eachFX000005FX000004FX000003F0010F0009F0007Apr 2020Apr 2020Sep 2019Nov 2018Aug 2018Jul 2018Entresto® (sacubitril/valsartan)0078-0777-610078-0777-3549 mg/ 51 mg100 count: 10 cards with 10 tablets eachFX000001F0006F0005F0004Dec 2019Oct 2019Aug 2019Oct 2018Entresto® (sacubitril/valsartan)0078-0696-610078-0696-3597 mg/ 103 mg100 count: 10 cards with 10 tablets eachFX000002F0007F0006F0005F0004Mar 2020Feb 2020Dec 2019Dec 2018Oct 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 DrugsTablet StrengthNDC NumbersCarton ConfigurationAzithromycin Tablets250 mg0781-5776-060781-5776-6950 count: 5 cards with 10 tablets eachDonepezil ODT Tablets5 mg0781-5276-060781-5276-6430 count: 3 cards with 10 tablets eachDonepezil ODT Tablets10 mg0781-5277-060781-5277-6430 count: 3 cards with 10 tablets eachHaloperidol Tablets0.5 mg0781-1391-13100 count: 10 cards with 10 tablets eachHaloperidol Tablets1 mg0781-1392-13100 count: 10 cards with 10 tablets eachHaloperidol Tablets2 mg0781-1393-13100 count: 10 cards with 10 tablets eachHaloperidol Tablets5 mg0781-1396-13100 count: 10 cards with 10 tablets eachHaloperidol Tablets10 mg0781-1397-13100 count: 10 cards with 10 tablets eachImipramine HCl Tablets25 mg0781-1764-13100 count: 10 cards with 10 tablets eachImipramine HCl Tablets50 mg0781-1766-13100 count: 10 cards with 10 tablets eachIsosorbide Dinitrate (ISDN) Tablets10 mg0781-1556-13100 count: 10 cards with 10 tablets eachIsosorbide Dinitrate (ISDN) Tablets20 mg0781-1695-13100 count: 10 cards with 10 tablets eachNaratriptan Tablets2.5 mg0781-5527-060781-5527-379 count: 1 card with 9 tabletsOndansetron Tablets8 mg0781-1681-333 count: 1 card with 3 tabletsOndansetron ODT4 mg0781-5238-060781-5238-6430 count: 3 cards with 10 tablets eachOndansetron ODT8 mg0781-5239-060781-5239-6430 count: 3 cards with 10 tablets eachOndansetron ODT8 mg0781-5239-060781-5239-8010 count: 1 card with 10 tabletsPerphenazine Tablets2 mg0781-1046-13100 count: 10 cards with 10 tablets eachPerphenazine Tablets4 mg0781-1047-13100 count: 10 cards with 10 tablets eachPerphenazine Tablets8 mg0781-1048-13100 count: 10 cards with 10 tablets eachRisperidone ODT0.5 mg0781-5310-060781-5310-0828 count: 7 cards with 4 tablets eachRisperidone ODT1 mg0781-5311-060781-5311-0828 count: 7 cards with 4 tablets eachRisperidone ODT2 mg0781-5312-060781-5312-0828 count: 7 cards with 4 tablets eachRisperidone ODT3 mg0781-5313-060781-5313-0828 count: 7 cards with 4 tablets eachRisperidone ODT4 mg0781-5314-060781-5314-0828 count: 7 cards with 4 tablets each
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.
Incidents & Injuries
The firms have received one report of a child ingesting haloperidol from a blister pack.
Remedy 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.
What Should You Do?
Stop using this product immediately. Contact the manufacturer for a New Instructions at no charge. If you experienced an injury, report it at SaferProducts.gov.
Frequently Asked Questions
Follow the consumer action instructions in the recall notice above. Most recalls require you to stop using the product and contact the manufacturer directly — either by calling the toll-free number listed in the official CPSC notice or by visiting the manufacturer's website. You generally do not need a receipt or original packaging to claim a remedy. The manufacturer is legally required to provide the remedy (New Instructions) at no cost to you.
Yes. If you were injured by a defective consumer product — whether recalled or not — you may have grounds for a product liability claim against the manufacturer and potentially the retailer. A recall notice can serve as evidence that the manufacturer was aware of the defect. Injuries that may support a claim include burns, lacerations, fractures, electric shock, choking incidents, and chemical exposure. Most product liability attorneys work on a contingency fee basis, meaning you pay nothing unless you win. Consult an attorney promptly, as statutes of limitation vary by state.
In most cases, no. CPSC-coordinated recall remedies are designed to be accessible without proof of purchase. Manufacturers typically ask consumers to self-certify ownership and may ask for photos of the product or its serial number. Some manufacturers request that you mail in a portion of the product (such as a cut cord or removed component) as proof of disposal. Check the specific remedy instructions for this recall for exact requirements. If you registered your product at the time of purchase, the process is usually even simpler.
If the original manufacturer has gone out of business, the recall remedy may no longer be available through them. In this case, contact CPSC directly at 1-800-638-2772 or cpsc.gov for guidance. If the brand was acquired by another company, the acquiring company may have assumed recall obligations. In some cases where a remedy is unavailable, CPSC advises consumers to safely dispose of the product. If you were injured by the product of a defunct company, consult a product liability attorney — parent companies, distributors, and retailers may still bear liability in some circumstances.