Reported Apr 21, 2021 · Terminated
TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured…
Novo Nordisk Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novo Nordisk Inc · 800 Scudders Mill Rd · Plainsboro, NJ · 08536-1606
Is this the product you have?
- TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only
- Manufactured byNovo Nordisk A/S, Bagsvaerd, Denmark
- Distributed by
Novo Nordisk IncPlainsboroNJ 08536NDC 0169-2550-90 (Pen)0169-2550-97 (Kit)
- Lot codes and dates
KP52829 exp 07/31/2022JP54181 exp 09/30/2021KP51059 exp 11/30/2021KP51865 exp 11/30/2021KP54179 exp 11/30/2022JP52179 exp 08/16/2021
- Amount recalled
- N/A
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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