The 2021 Class II recall of liraglutide sample pens, initiated over storage below the required temperature, carries the status terminated in the enforcement file.
Silver Spring, Maryland, 21 April 2021 — The Food and Drug Administration enforcement file records a Class II recall initiated by Novo Nordisk Inc. of Plainsboro, New Jersey, on 22 March 2021 and classified on 10 June 2021. The record covers sample prefilled pens of Saxenda, a liraglutide injection, distributed nationwide and marked not for resale.
The reason recorded is temperature abuse, with the record stating that product samples were stored below 32 degrees Fahrenheit, outside the storage requirements. The status on the record is terminated, the only one of the recall records on this wire that is closed.
Source documents
-
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)
- Identifier
- Recall number D-0618-2021
- As the record states
- 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.
- Recalling firm
- Novo Nordisk Inc
- Firm location
- Plainsboro, NJ, United States
- Classification
- Class II
- Status on the record
- Terminated
- Quantity
- N/A
- Distribution
- Nationwide in the USA
- Initiated
- 2021-03-22
- Classified
- 2021-06-10