The Recall Desk
HighFDA (Drugs)·D-0231-2023·Announced 2023-02-01

Pharmacy Innovations polidocanol injectable vials recalled for lack of sterility

Pharmacy Innovations is recalling polidocanol injectable vials nationwide after FDA inspection revealed insanitary conditions at the manufacturing facility that compromised sterility assurance.

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: This is an FDA Class II recall of an injectable drug for lack of sterility assurance due to facility conditions. No illnesses or hospitalizations have been reported. This meets the rubric criterion for High (3) severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Pharmacy Innovations is recalling all polidocanol 50mg/ml (5%) injectable vials distributed nationwide. FDA inspection of the facility at 2936 W 17th St., Erie, Pennsylvania revealed insanitary conditions that resulted in a lack of assurance of sterility.

The affected vials carry the lot code t20221025@32. Polidocanol is a prescription injectable used in medical procedures. The lack of sterility assurance represents a significant risk to patients who received injections from affected vials.

The recalled product

Product
POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer
Pharmacy Innovations
Category
Drug — Injectable
Hazard
  • lack-of-sterility
  • infection-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)

  • t20221025@32

Distribution

Distributed nationwide across the United States.

Related recalls

Same category