Drug product
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
D-0201-2026
Product summary
- Event
- Event 97935
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9600 containers
- Official record key
drug-enforcement:D-0201-2026
Official wording
Reason: cGMP deviations
Code information: Lot #: A162301, Exp. Date 9/26; A162401, Exp. Date 4/27 & A162202, Exp. Date 11/25.
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations