TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)
Check against the official notice below — it lists the full affected range.
Novo Nordisk Inc. is recalling TRESIBA FlexTouch insulin degludec injection 200 units/mL sample pens that were distributed nationwide in the USA. The product samples were stored at temperatures below 32°F, which violates proper storage requirements. This temperature abuse could result in lack of efficacy and damage to the cartridge and pen-injectors. The recall affects six lot codes with expiration dates ranging from August 2021 to November 2022.
The affected lot codes are KP52829 (exp 07/31/2022), JP54181 (exp 09/30/2021), KP51059 (exp 11/30/2021), KP51865 (exp 11/30/2021), KP54179 (exp 11/30/2022), and JP52179 (exp 08/16/2021). The source document does not specify a remedy or action for consumers to take.
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: KP52829 exp 07/31/2022; JP54181 exp 09/30/2021; KP51059 exp 11/30/2021; KP51865 exp 11/30/2021; KP54179 exp 11/30/2022; JP52179 exp 08/16/2021
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.