Status
Terminated
Drug Enforcement D-0237-2023
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Classification
Class II
Report Date
February 1, 2023
Termination Date
July 31, 2024
Product Information
- Product description
- 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.
- Product quantity
- N/A
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Pharmacy Innovations
- Address
-
2936 W 17th St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0237-2023
- Event ID
- 91332
- Recall initiation date
- December 22, 2022
- Center classification date
- January 26, 2023
- Code info
- t20221011@25 t20221011@55 t20221020@26 t20221104@44 t20221027@6 20221019@44 t20221026@41
- More code info
- —