Edetate Disodium Ophthalmic Solution Recalled for Sterility Concerns
Pharmacy Innovations is recalling Edetate Disodium 1% ophthalmic solution nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.
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 due to sterility assurance failure from insanitary facility conditions. No illnesses or injuries reported. Per rubric, risk-of-harm products without reported injury score at High (3).
Plain-English summary
Pharmacy Innovations is recalling all lots of Edetate Disodium 1% ophthalmic solution, a prescription-only veterinary eye treatment supplied in 3 mL droptainer bottles. The product was distributed nationwide in the USA. Affected batch codes include t20221116@36, t20221005@3, t20221021@32, t20221110@60, and t20221130@10.
An FDA inspection of the manufacturer's facility in Erie, Pennsylvania discovered insanitary conditions during manufacturing that compromised the sterility assurance of this product. Ophthalmic solutions must be completely sterile to prevent serious eye infections.
No illnesses or adverse events have been reported in connection with this recall. Animal care providers and those with this product should discontinue use and contact their supplier or veterinarian for guidance on obtaining a replacement from a different manufacturer.
The recalled product
- Product
- EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Hazard
- sterility-failure
- 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)
- t20221116@36 t20221005@3 t20221021@32 t20221110@60 t20221130@10
Distribution
Distributed nationwide across the United States.
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