The Recall Desk
HighFDA (Drugs)·D-0226-2023·Announced 2023-02-01

FDA Recalls Papaverine/Phentolamine Injectable Vials Due to Sterility Concerns

Pharmacy Innovations has recalled papaverine/phentolamine injectable vials in multiple concentrations due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of injectable pharmaceutical product with lack of sterility assurance due to insanitary facility conditions. The source text does not report any illnesses or injuries, so this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Pharmacy Innovations is recalling papaverine/phentolamine injectable vials in five different concentrations (30mg/0.5mg/ml, 30mg/1mg/ml, 30mg/2mg/ml, 30mg/3mg/ml, and 30mg/5mg/ml) distributed nationwide in the USA. The recall affects lot codes t20221011@7, t20221020@34, t20221018@58, t20221013@15, and t20221104@39.

The recall was initiated due to lack of assurance of sterility. During an FDA inspection, insanitary conditions were discovered at the Pharmacy Innovations facility located in Erie, Pennsylvania. These conditions pose a risk that the injectable vials may not meet sterility requirements.

Patients who have received or are currently using affected vials should contact their healthcare provider immediately. Healthcare providers and patients should not use any vials from the recalled lot codes. For more information, patients and providers can contact the FDA or Pharmacy Innovations.

The recalled product

Product
PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/2MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/3MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/5MG/ML (1ML V
Manufacturer
Pharmacy Innovations
Category
Drug — Injectable Pharmaceutical
Hazard
  • lack-of-sterility
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • t20221011@7 t20221020@34 t20221018@58 t20221013@15 t20221104@39

Distribution

Distributed nationwide across the United States.

Related recalls

Same category