Recalls / Class II
Class IID-0617-2021
Product
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)
- Brand name
- Ozempic
- Generic name
- Semaglutide
- Active ingredient
- Semaglutide
- Route
- Subcutaneous
- NDCs
- 0169-4130, 0169-4136, 0169-4132, 0169-4772, 0169-4181
- FDA application
- NDA209637
- Affected lot / code info
- KP50867, 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
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.
Recalling firm
- Firm
- Novo Nordisk Inc
- Manufacturer
- Novo Nordisk
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 800 Scudders Mill Rd, N/A, Plainsboro, New Jersey 08536-1606
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-03-22
- FDA classified
- 2021-06-10
- Posted by FDA
- 2021-04-21
- Terminated
- 2022-12-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0617-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.