Drug product
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117 (855) 792-6676
D-0526-2017
Product summary
- Firm
- Synergy Rx
- Event
- Event 76472
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0526-2017
Official wording
Reason: Lack of Assurance of Sterility: There are also CGMP Deviations.
Code information: All Lots
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Sterility assurance
Lack of Assurance of Sterility