Drug product
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
D-0185-2026
Product summary
- Event
- Event 97820
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 555 tubes
- Official record key
drug-enforcement:D-0185-2026
Official wording
Reason: CGMP Deviations
Code information: Lot Code D54361, exp 8/31/2027
Distribution pattern: CA, CO, FL, PR, WA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations