Drug Safety Alerts

TRUEplus® 0.3cc Insulin Syringes Consumer-Level Recall

8/31/18

On August 31, 2018, Trividia issued a consumer-level recall of TRUEplus^® 0.3cc insulin syringes. This recall was issued because certain lots of TRUEplus and Store Brand 0.3cc Insulin Syringes manufactured during a specific timeframe contain a defect in which a small crack in the top end of the barrel near the needle creates the inability to aspirate insulin into the syringe barrel from the insulin vial. Inability to draw insulin into the syringe deems the syringe unusable.

There are 26 affected lots that were manufactured for Trividia Health from April 30, 2018 thru August 21, 2018, of which 3 lots were distributed by Trividia Health for sale in the United States. The other 23 affected lots have been contained and not released in the market. Trividia Health has not received any reports of patient injuries related to this voluntary recall.

A complete list of the affected products is provided here:

CVS Caremark Response: These products are not carried by the CVS Caremark mail Service Pharmacies.

For more information on this recall, health care providers may contact the Trividia Health Customer Service Department at 1-800-588-1685,Monday through Friday, 8:00 am to 5:00 pm (ET) or visit www.trividiahealth.com. You may also contact the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.