
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl
Lack of Assurance of Sterility
Page 28 of 40 · 1,986 total recalls

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Chemical contamination: Presence of benzene

Chemical contamination: Presence of benzene

Chemical contamination: Presence of benzene

Chemical contamination: Presence of benzene

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term...

Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

Non-Sterility: microbial contamination identified as Paenibacillus phoenicis

Undeclared wheat.

Undeclared wheat and Yellow #6.

Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Unapproved design changes to the products outside of the 510(k) clearance.

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating...

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating...

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating...

Undeclared Allergens: Soy & Wheat. The firm was notified by a customer that the product is labeled as Savannah Bee...

The product states wild caught marine collagen and eggshell membrane collagen in ingredient statement but does not...

Potential Salmonella contamination.

Potential Salmonella contamination.

Potential Salmonella contamination.

Positive Salmonella contamination

Potential Salmonella contamination

Undeclared egg

Undeclared Sesame, Soy, Wheat

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been...
Independent news on labor, safety, and accountability.