Drug product
Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
D-1096-2023
Product summary
- Firm
- Ecometics, Inc.
- Event
- Event 92857
- Status
- Completed
- Classification
- Class II
- Quantity
- a) 9816 bottles; b) 10,776 bottles
- Official record key
drug-enforcement:D-1096-2023
Official wording
Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Code information: Lot: 9E098A
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations