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FDAMarch 22, 2021drug

Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Terminated

Brands named

novo nordisknovo

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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