FDAClass IApril 21, 2021

Fiasp PenFill recall

Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured…

Why was Fiasp PenFill 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

KS6BF84, Exp 06/30/2022

Product
Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured…
Recalling firm
Novo Nordisk Inc
Quantity
N/A
Distribution
Nationwide in the USA
Recall date
April 21, 2021
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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