Epinephrine syringes recalled. Needle clogging can have ‘consequences including death’
Adamis Pharmaceuticals recalled four lots of SYMJEPI (epinephrine) Injection Pre-Filled Single-Dose Syringes because a needle-clogging problem could occur when the epinephrine is needed to save a life.
And there have been complaints about SYMJEPI syringes.
Why are the SYMJEPI syringes being recalled?
The syringes contain epinephrine, which prevents the deadly allergic reaction called anaphylaxis. Clogged needles can mean no epinephrine or not enough epinephrine gets into the person having the reaction. The first line of the company-written, FDA-posted recall notice’s risk statement puts it plainly:
“If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death.”
And, Adamis says it’s received two customer complaints about three syringes “regarding difficulty in dispensing the product,” but says it can’t confirm that those complaints are linked to this recall.
What epinephrine dispensers are being recalled?
SYMJEPI (epinephrine) Injection Pre-Filled Single-Dose Syringes, in two strengths, 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL). They come two syringes per carton..
One lot of the lesser strength, which comes in gray packaging, lot No. 21101Y, expiration 11/30/2022.
Three lots of the higher strength, in blue packaging, lot Nos. 21021W, expiration 8/31/2022; 21081W, expiration 11/30/2022; and 21102W, expiration 2/28/2023.
What you should do if you have recalled syringes?
The recall notice says you can return them or toss them out, but the suggestion here is return them and request a refund.
US WorldMeds markets and distributes SYMJEPI in the United States and is handling the recall for Adamis. To contact US WorldMeds, e-mail medinfo@usworldmeds.com or call 888-900-8796, Monday through Friday, 8 a.m. to 4 p.m., Eastern time.
If this product or any drug causes a medical problem, after notifying a medical professional, tell FDA via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088. Only then do you notify the drug company.
This story was originally published March 23, 2022 at 7:55 AM with the headline "Epinephrine syringes recalled. Needle clogging can have ‘consequences including death’."
