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Class II · ModerateRecall completed

Ozempic

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberKP50867, exp 10/31/2022, KP53021, exp 04/30/2023, KP52338, exp 02/28/2023, JP54354, exp 08/31/2022, KP50676, exp 10/31/2022, KP51434, exp 11/30/2022, KP51491, exp 11/30/2022, KP51781, exp 01/31/2023, KP52249, exp 01/31/2023, KP52270, exp 01/31/2023, KP52722, exp 01/31/2023, KP52973, exp 01/31/2023, KP53031, exp 01/31/2023, KP53221, exp 12.04.2023, KP53369, exp 01/31/2023
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byNovo Nordisk A/S, Bagsvaerd, Denmark
Brand nameOZEMPIC
Generic nameSEMAGLUTIDE
Active ingredient(s)SEMAGLUTIDE
Distributed by / forNovo Nordisk Inc
NDC0169-4132-90
Show the full FDA record
Full product labelOZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)
Recalling firmNovo Nordisk Inc
DistributionNationwide in the USA
QuantityN/A
Recall initiated2021-03-22
Report date2021-04-21
Recall completed2022-12-09
Recall numberD-0617-2021
ClassificationClass II
FDA statusTerminated
Origin on filePlainsboro NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.