Epinephrine Injections Recalled Over Potentially Deadly Health Risk: FDA Notice

Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

A pharmaceutical company is recalling multiple lots of epinephrine injections due to concerns about sterility and the possible presence of particulate matter, according to a warning published on the Food and Drug Administration’s website.

Epinephrine is meant for the emergency treatment of allergic reactions such as anaphylaxis resulting from insect stings or bites, drugs, foods, diagnostic testing substances, and other allergens. It is also used to increase arterial blood pressure in adults who have hypotension associated with septic shock, American Reagent said.

American Regent, Inc., said in a Sept. 3 notice that the recall impacts epinephrine injections, in 30 mg per 30 ml doses, contained in multi-dose vials. It was issued after customers submitted complaints over “leaking and cracked vials, resulting in lack of assurance of sterility,” it said.

After an investigation, the company found particulate matter including nylon, acrylic, cellulosic, glass, and polyethylene in the impacted products, according to the notice.

The company warned that people using the potentially contaminated injections may suffer “serious adverse health consequences” including a type of blood clot in the lungs known as a pulmonary embolism, which can cause death or permanent organ damage.

The contaminants can also cause “vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions,” it said.

“Cracked vials can compromise the integrity of the container resulting in loss of sterility and potential contamination which can pose a serious risk for patients,” the company added.

So far, American Regent said it hasn’t received any reports from customers or health care providers about health-related events connected to the recall.

The impacted lot numbers are 25128L1C0, 25280L1C0, and 26108L1C0, and were distributed nationwide.

The company said it will notify individual customers and distributors by letter while adding it will arrange for the return or replacement of the product. Healthcare, retail, and distribution facilities that still have the product should stop selling them and return it to the place of purchase or discard it.

The company provided a list of the products, expiration dates, and lots that are impacted by the recall:

Epinephrine Injection, USP (NDC: 0517-3030-01)

On the FDA’s website, the company also provided a list of contact phone numbers and email address for people with concerns or questions.