FDA Recall D-0621-2021

Novo Nordisk Inc · Plainsboro, NJ

Class I — life-threatening Terminated 627 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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)

Lot / code: 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

Quantity: N/A

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.

Recall record

Recall number: D-0621-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2021-03-22
Classified by FDA Center: 2021-06-10
FDA published: 2021-04-21
Terminated: 2022-12-09
Recalling firm: Novo Nordisk Inc
Firm location: Plainsboro, NJ

Drug identification

Brand name(s): TRESIBA
Generic name(s): INSULIN DEGLUDEC
Manufacturer(s): Novo Nordisk
NDC(s): 0169-2550, 0169-2660, 0169-2662
Route(s): SUBCUTANEOUS

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