Certain Lots of Quillivant XR May Potentially Have Quality/Efficacy Issues

Tris Pharma released 3 lots of product to address the shortage
Tris Pharma released 3 lots of product to address the shortage

To address the current shortage of Quillivant XR (methylphenidate HCl extended-release) oral suspension, Tris Pharma has released 3 lots of product, however these lots may possibly have quality/efficacy issues.

Quillivant XR, a central nervous system (CNS) stimulant, is indicated to treat attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and older. It is supplied as a 5mg/mL strength powder for oral suspension after reconstitution in 60mL, 120mL, 150mL, and 180mL bottles. The following lots are being released for distribution this month to alleviate the current drug shortage, however they may not meet dissolution test specifications, which could affect the drug quality and efficacy: 

  • 300mg: Lot# 9519T (Exp 04/2020)
  • 600mg: Lot# 9518T (Exp 04/2020)
  • 900mg: Lot# 9517T (Exp 04/2020)

The full list of Quillivant XR lots currently on the market that are within expiry are listed here. These lots may also be potentially impacted but they have met all other product quality test specifications, according to Tris Pharma.

Healthcare providers should continue to follow the FDA-approved labeling instructions for use of all lots of Quillivant XR. Any adverse reactions or quality problems associated with Quillivant XR should be reported to the FDA's MedWatch Adverse Event Reporting program.

Related Articles

For more information call (732) 940-0358 or visit FDA.gov.