Sandoz Losartan Potassium & Ezetimibe Drug Recall [US]


Sandoz Losartan Potassium & Ezetimibe Drug Recall [US]

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US FlagUS/Washington: Sandoz Inc., a Princeton, New Jersey establishment, recalls an estimated 636,000 Losartan Potassium Prescription Drug and Ezetimibe Prescription Drug Bottles due to suspected failure to meet child-resistant closure requirements as required by the US Poison Prevention Packaging Act and consequential risk of choking, ingestion and poisoning, all serious health and safety hazards.

CPSC: http://ht.ly/2wC230proqE

Direct link: https://www.cpsc.gov/Recalls/2019/Sandoz-Recalls-Losartan-Potassium-and-Ezetimibe-Prescription-Drug-Bottles-Due-to-Failure-to-Meet-ChildResistant-Closure-Requirements

Additional information:
The US Consumer Product Safety Commission (“CPSC”) reports this recall involves Bottles of prescription medications Losartan Potassium and Ezetimibe from Sandoz with certain identified batch/lot numbers.

The recalled bottles have the brand, “Sandoz” printed on them along the name of the specific medication, dosage and NDC on the front bottle labels and the batch/lot numbers and expiration dates on the side of the bottle labels. The recall includes the following prescription medications:

  • Ezetimibe, sold in 30-count bottles of 10 mg tablets with an NDC designation of 0781-5690-31, and a batch/lot code as follows:
    • JE4491 with an expiration date of Aug-2020
    • JE4492 with an expiration date of Aug-2020
    • JE4493 with an expiration date of Aug-2020
    • JE4495 with an expiration date of Aug-2020
    • JG0308 with an expiration date of Sep-2020
    • JG0310 with an expiration date of Sep-2020
    • JG0311 with an expiration date of Sep-2020
    • JG0312 with an expiration date of Sep-2020
    • JG5061 with an expiration date of Sep-2020
    • JG5063 with an expiration date of Sep-2020
    • JK8921 with an expiration date of Oct-2020
    • JK8922 with an expiration date of Oct-2020
    • JK8923 with an expiration date of Oct-2020
    • JK8924 with an expiration date of Oct-2020
    • JL5535 with an expiration date of Oct-2020
    • JM2253 with an expiration date of Oct-2020
    • JM2254 with an expiration date of Oct-2020
    • JM2255 with an expiration date of Oct-2020
    • JM2257 with an expiration date of Oct-2020
    • JM2258 with an expiration date of Oct-2020
    • JM2259 with an expiration date of Oct-2020
    • JM5986 with an expiration date of Oct-2020
    • JM5987 with an expiration date of Oct-2020
  • Ezetimibe, sold in 90-count bottles of 10 mg tablets with an NDC designation of 0781-5690-92 and batch/lot codes as follows:
    • JE4481 with an expiration date of Aug-2020
    • JG0249 with an expiration date of Sep-2020
    • JK8989 with an expiration date of Oct-2020
    • JN0764 with an expiration date of Jan-2021
  • Losartan Potassium sold in 30-count bottles of 50 mg tablets with an NDC designation of 0781-5701-31 and a batch/lot code as follows:
    • HV9471 with an expiration date of Feb-2020

Please consult the photograph above for details of the product’s packaging, design and retail presentation. Additional images of the recalled drugs can be found on the Web sites listed above.

According to the CPSC, the prescription drug packaging is not child resistant as required by the US Poison Prevention Packaging Act, posing both ingestion and poisoning risks if swallowed by children.

If you believe you have purchased or have in your possession any of the recalled Prescription Drug Bottles, please do not use them. Instead, you should immediately secure the Bottles to keep them out of the sight and reach of children and contact Sandoz for a free replacement child resistant bottle cap. Once the medication is secured, consumers can continue to use the medication as directed.

If you have any questions about this recall notification, please contact Sandoz toll-free at 1-800-525-8747 from 8:30 AM to 5:00 PM, Eastern Standard Time, Monday to Friday.

You can also reach the companies on the Web at http://www.us.sandoz.com and click on “Patients and Customers” then “Product Safety Notices”.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Drugs or Medications, please search for “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to products made, marketed and/or sold by Sandoz, please search for “Sandoz” using the Search Box at the top of this page.

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More information about this recall:
CPSC recall number: 19-194
Recalls Direct RIN: 11977-2019
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in the United States [external: new window opens]:
==> https://www.saferproducts.gov/CPSRMSPublic/Incidents/ReportIncident.aspx
Search for a recalled product on the US CPSC Web site [external: new window opens]:
==> https://www.cpsc.gov/Recalls/

We welcome your feedback:
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E. & O. E.

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