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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
Part of a larger recall action
This product is one of 59 recalled by Pharmacy Innovations under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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