Drug product
YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.
D-1097-2023
Product summary
- Firm
- Ecometics, Inc.
- Event
- Event 92857
- Status
- Completed
- Classification
- Class II
- Quantity
- a) 5028 bottles; b) 9809 bottles
- Official record key
drug-enforcement:D-1097-2023
Official wording
Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Code information: Lot: 0E267A
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations