FDAFDA · Food and drugs·Recall number D-0619-2021
TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit)
Published April 21, 2021 · Recall initiated: March 22, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TRESIBA
- Manufacturer
- Novo Nordisk Inc
- Distributor
- Nationwide in the USA
- Lot
- JP52771 exp 09/30/2021; JP53136 exp 06/30/2021; KP50575 exp 01/31/2022; KP50976 exp 01/31/2022; KP51813 exp 04/30/2022; KP52035 exp 04/30/2022; KP52117 exp 04/30/2022; KP52440 exp 06/30/2022; KP52461 exp 04/30/2022; KP52616 exp 06/30/2022; JP52361 exp 08/01/2021
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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