Class II · Moderate risk
SEMAGLUTIDE 20mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
OZEMPIC (semaglutide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
OZEMPIC (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)
Affected NDCs
0169-4132-90
0169-4132-97
Compare with the code on your package — it is the most precise check available.
Drug: Semaglutide
- Recalling firm
- Novo Nordisk Inc
- NDC code
- 0169-4132-90
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0617-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Semaglutide recalls
See all
Class II · Moderate risk
SEMAGLUTIDE 10mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 7.5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 2.5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Other recalls by Novo Nordisk Inc
All 2021 recalls
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class I · High risk
Xultophy 100/3.6
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.
Class II · Moderate risk
ViCTOZA (liraglutide)
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.
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