Adverse Events and Recalls

The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.

The company is expanding their April 2017 voluntary recall of phenobarbital tablets.

The company is recalling one lot of 25% Dextrose injection after particulate matter was found within an internal sample syringe.

The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

The company is voluntarily recalling product due to particulate matter.

The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

The company voluntarily recalled the product due to detached needles on the syringe in the kit.

The company is voluntarily recalling one lot of product due to particulate matter.

The company is voluntarily recalling liquid products due to possible Burkholderia cepacia contamination.

The company recalls products due to sterility concerns.

The company has recalled one lot of 50% magnesium sulfate injection, USP due to particulates.

Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.

The company issues a voluntary recall of a lot of 0.9% sodium chloride solution due to particulate matter.

Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.

Abbott’s Compounding Pharmacy voluntarily recalls sterile products due to lack of sterility assurance.

The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.

The company voluntarily recalls select lots of Adrucil due to particulate matter.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.