Recalls / Class II
Class IID-0204-2023
Product
EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Affected lot / code info
- t20221116@36 t20221005@3 t20221021@32 t20221110@60 t20221130@10
Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recalling firm
- Firm
- Pharmacy Innovations
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2936 W 17th St, N/A, Erie, Pennsylvania 16505-3929
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-12-22
- FDA classified
- 2023-01-26
- Posted by FDA
- 2023-02-01
- Terminated
- 2024-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0204-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.