FDA Drug recall D-0613-2021

Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample

• FDA Drug
• Class I
• terminated
• Published 2021-04-21

On 2021-04-21 the FDA classified a Class I recall of Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample by Novo Nordisk, citing 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 t….

Read the official FDA Drug notice

Product

Fiasp (insulin aspart 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 0169-3201-90

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0613-2021%22

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