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FDA (Drug enforcement)Recalled 2021-03-22closedclass ii

Novo Nordisk Inc: Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordis

Is my product affected?

Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit)

  • Brand SAXENDA

Check against the official notice below — it lists the full affected range.

What happened

Novo Nordisk Inc. is recalling Saxenda (liraglutide) injection 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 of the medication and damage to the cartridge and pen-injector components. The affected lots are identified by kit codes K1620A1, B2020A, I2320A, H1020A, and J0520A, with corresponding pen lot codes and expiration dates ranging from November 2021 to May 2022.

The recall notice does not specify a remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: K1620A1 (Kit); KZFH714 (Pen) exp 05/31/2022; B2020A (Kit); JZFF482 (Pen) exp 11/30/2021; I2320A (Kit); KZFH714 (Pen) exp 05/31/2022; H1020A (Kit); KZFH714 (Pen) exp 05/31/2022; J0520A(Kit); KZFH714 (Pen) exp 05/31/2022

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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