Class II · Moderate risk Completed
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro…
Reason CGMP Deviations
Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was 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 was recalled
Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91
- Recalling firm
- Novo Nordisk Inc
- NDC code
- 0169-3205-91
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0612-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Insulin recalls
See all
Class II · Moderate risk Ongoing
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ…
Reason Lack of Assurance of Sterility: Malformed crimped collar seal
Class I · High risk Terminated
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in…
Reason Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk Terminated
Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton…
Reason Labeling: Missing label on the vial
Class I · High risk Completed
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC…
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
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