TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90
Reported: April 21, 2021 Initiated: March 22, 2021 #D-0620-2021
Product Description
TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90
Reason for Recall
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.
Details
- Recalling Firm
- Novo Nordisk Inc
- Units Affected
- N/A
- Distribution
- Nationwide in the USA
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90. Recalled by Novo Nordisk Inc. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 21, 2021. Severity: Critical. Recall number: D-0620-2021.
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