Pennsylvania recalls

Due to product exhibiting potential to generate either invalid or false negative results.

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

Drainable large pouch may leak due to manufacturing issue.

Drainable large pouch may leak due to manufacturing issue.

Drainable large pouch may leak due to manufacturing issue.

Due to adapter not being properly aligned or locked in place.

Cribs sold in the USA are missing two access door warning labels.

Labeling mix-up resulting in the incorrect lot outer packaging of product.

Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.

A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.

There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

Produced Without Benefit of Inspection

Foreign plastic material discovered on fill line.

Foreign plastic material discovered on fill line.

Foreign plastic material discovered on fill line.

Foreign plastic material discovered on fill line.

Undeclared allergen ingredients (sesame and wheat) in Zaatar Spice mix.

This product has the possibility of contamination with rodent hair.

Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.

Lack of Assurance of Sterility

Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.

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

A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification.

Bridgewater, New Jersey, Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride I

Product Contamination

The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional stability, and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.

The folding mechanism on the blade can fail to remain properly secured in the closed position, posing a laceration hazard.