Ceftazidime Injectable Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling Ceftazidime Intravitreal injectable nationwide due to lack of sterility assurance identified during FDA inspection of 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: This is an injectable pharmaceutical product where manufacturing sterility assurance is absent due to insanitary facility conditions. Although no illnesses have been reported, the potential risk of harm is significant given that intravitreal injections require strict sterility standards.
Plain-English summary
Pharmacy Innovations is recalling Ceftazidime Intravitreal (1ML vial, 22.5 MG/ML) nationwide.
The recall was prompted by an FDA inspection that revealed insanitary conditions at the manufacturing facility. These conditions compromised sterility assurance, creating a risk that products may not meet the sterility standards required for injectable medications.
The affected product has code t20221028@11 and was distributed nationwide. Patients who have received this medication should contact their healthcare provider. Healthcare providers should not use remaining product and should contact Pharmacy Innovations with any questions.
The recalled product
- Product
- Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Intravitreal Injection
- Hazard
- contamination-risk
- lack-of-sterility
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)
- t20221028@11
Distribution
Distributed nationwide across the United States.
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