Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not fo...

FDA Drug Recall #D-0613-2021 — Class I — March 22, 2021

Recall Summary

Recall Number D-0613-2021
Classification Class I — Serious risk
Date Initiated March 22, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Novo Nordisk Inc
Location Plainsboro, NJ
Product Type Drugs
Quantity N/A

Product Description

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 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.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

KS6BX63 exp 10/31/2022; KS6AK76 exp 05/31/2022; KS6BR92 exp 09/30/2022

Other Recalls from Novo Nordisk Inc

Recall # Classification Product Date
D-0619-2021 Class I TRESIBA FlexTouch (insulin degludec injection) ... Mar 22, 2021
D-0618-2021 Class II Saxenda (liraglutide) Injection, 18 mg/3 mL (6 ... Mar 22, 2021
D-0614-2021 Class I Levemir FlexTouch (insulin detemir) injection, ... Mar 22, 2021
D-0611-2021 Class I Fiasp FlexTouch (insulin aspart injection) 100 ... Mar 22, 2021
D-0623-2021 Class I Xultophy 100/3.6 (insulin degludec and liraglut... Mar 22, 2021

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.