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.
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 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
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.
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.
See all 59 products in this recall →Related recalls
Same manufacturer · Pharmacy Innovations
See all →- HighEdetate Disodium Ophthalmic Solution Recalled for Sterility Concerns
FDA (Drugs) · 2023-02-01
- HighInjectable Hydroxocobalamin Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-02-01
- HighFDA Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2023-02-01
- HighMethylcobalamin Injectable Recall Due to Facility Sterility Assurance Failure
FDA (Drugs) · 2023-02-01
- HighInjectable vitamin B-complex products recalled for lack of sterility assurance
FDA (Drugs) · 2023-02-01
Same hazard · contamination risk
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Vancomycin Injection Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Similar recalls
- HighCeftazidime Intravitreal Solution Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- HighCeftazidime Sterile Ophthalmic Solution Lacks Sterility Assurance
FDA (Drugs) · 2022-02-02
- HighCefepime for Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-05-24
- SevereEdge Pharma Recalls Ceftazidime Sterile Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2021-01-27
- HighFDA Recalls Cefuroxime Intravitreal Injections for Sterility Defect
FDA (Drugs) · 2022-11-09
- HighCeftriaxone Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-05-24