All Recalls

CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of sterility assurance: leaking bags

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

Lack of Assurance of Sterility

Sterility of device is compromised due to a sterile barrier breach

LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.

Sterility of device is compromised due to a sterile barrier breach

Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.

Sterility of device is compromised due to a sterile barrier breach

Sterility of device is compromised due to a sterile barrier breach

Distributed product did not undergo proper release testing.

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.