Saxenda Injection, Solution
FDA Recall NDC 0169-2800
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Saxenda (NDC 0169-2800). A significant event, classified as Class II, was initiated on Mar 22, 2021 by Novo Nordisk. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Mar 22, 2021
Apr 21, 2021
N/A
Recall Profile & Regulatory Data
Event ID
87537
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Novo Nordisk Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 09, 2022
Product Description
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)
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
0169-2800-15Product
0169-2800-90Product
0169-2800-97Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
