Clinical Updates — Clinical Updates
Pine Pharmaceuticals Announces Voluntary Recalls, Including Avastin
On October 2, Pine Pharmaceuticals contacted ASRS with notification of two voluntary recalls it is issuing following a recent inspection by the U.S. Food and Drug Administration (FDA). The recalls include repackaged Avastin as well as other products for ocular use. There have been no reported adverse events associated with the impacted products.
Pine notes in its communication to customers that the inspection identified “a potential lack of sterility assurance for repackaged Avastin intended to be sterile, when produced with specific equipment used in select fill lines.” Pine has been able to shift production to unimpacted lines and expects any product shortages to be temporary. However, it is requesting that customers only order a week’s supply at a time and notes that it may have to implement allocation limits.
Finally, customers using item #987 (Norm-Ject® Less Fill, silicone-free syringe) will need to choose a different syringe as the production of this product is temporarily unavailable due to process limitations.
Full information on the recall, including affected lot numbers and product return information is here:
If you need additional assistance, please contact Allison Madson, vice president of health policy, at firstname.lastname@example.org.
(Published October 2, 2023)