Drug product
SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC ACID 20%. 2.5%5-FU, SALICYCLIC ACID 20%, 5-FU 2.5% CREAM, SALICYCLIC ACID 20%/5-FU 2.5% MEDICATION STICK, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
D-0543-2017
Product summary
- Firm
- Synergy Rx
- Event
- Event 76472
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0543-2017
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