Recalls / Class II
Class IID-0237-2023
Product
TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.03% (10ML DROPPER) OPHTHALMIC, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Affected lot / code info
- t20221011@25 t20221011@55 t20221020@26 t20221104@44 t20221027@6 20221019@44 t20221026@41
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-0237-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.