Lidocaine-PF Injectable Vials Recalled for Sterility Assurance Deficiency
Pharmacy Innovations is recalling Lidocaine-PF 5% injectable solution nationwide due to insanitary facility conditions that compromised sterility assurance, discovered during FDA inspection.
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 an injectable drug with documented sterility assurance failure due to facility contamination. While no illnesses have been reported, this represents a risk-of-harm product where injury has not yet occurred, fitting the High severity criterion.
Plain-English summary
Pharmacy Innovations is recalling Lidocaine-PF 5% injectable solution (5mL vials) distributed nationwide. The product is a prescription anesthetic used for local and regional anesthesia.
An FDA inspection of the manufacturing facility revealed insanitary conditions that resulted in loss of assurance of sterility. Sterility is a critical quality attribute for injectable medications and its compromise poses a potential risk to patient safety.
The recalled product is identified by lot codes t20221011@36 and t20221108@24. Healthcare providers and patients who have received this product should immediately cease use and consult their healthcare provider or pharmacist for guidance.
Patients and healthcare facilities should return any unused vials from the recalled lots to their pharmacy. Do not attempt to use or administer any vials from the affected lots.
The recalled product
- Product
- LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable / Anesthetic
- Hazard
- sterility-assurance
- contamination
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@36 t20221108@24
Distribution
Distributed nationwide across the United States.
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