Phenol 10% Injectable Vials Recalled for Sterility Assurance Failure
Pharmacy Innovations recalls Phenol 10% injectable vials distributed nationwide due to 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 FDA Class II recall involves an injectable pharmaceutical with compromised sterility assurance due to insanitary facility conditions. Although no illnesses or injuries have been reported, the product poses a potential risk of serious harm through infectious disease if contaminated vials are used.
Plain-English summary
Pharmacy Innovations is recalling Phenol 10% injectable vials distributed nationwide in the United States. The product is packaged in 10ml vials with code 20221017@50 and manufactured at the company's facility in Erie, Pennsylvania. Phenol 10% is a prescription-only injectable medication.
The FDA discovered insanitary conditions at the manufacturing facility during inspection. These conditions resulted in inability to assure the sterility of the injectable product. Lack of sterility assurance in injectable medications poses a risk of serious infection if contaminated vials are administered to patients.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable Pharmaceutical
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)
- 20221017@50
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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