TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit)
Check against the official notice below — it lists the full affected range.
Novo Nordisk Inc. is recalling TRESIBA FlexTouch insulin degludec injection 100 units/mL sample pens distributed nationwide in the USA. The product samples were stored at temperatures below 32°F, which does not meet the required storage conditions. This temperature abuse could result in lack of efficacy and damage to the cartridge and pen-injectors.
The recall affects multiple lot numbers with expiration dates ranging from January 2021 through June 2022. According to the recall record, no remedy is specified for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Nationwide in the USA Quantity: N/A Lot/code info: JP52771 exp 09/30/2021; JP53136 exp 06/30/2021; KP50575 exp 01/31/2022; KP50976 exp 01/31/2022; KP51813 exp 04/30/2022; KP52035 exp 04/30/2022; KP52117 exp 04/30/2022; KP52440 exp 06/30/2022; KP52461 exp 04/30/2022; KP52616 exp 06/30/2022; JP52361 exp 08/01/2021
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.