Drug product
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
D-0204-2026
Product summary
- Event
- Event 97935
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8184 bottles
- Official record key
drug-enforcement:D-0204-2026
Official wording
Reason: cGMP deviations
Code information: Lot #: A322301, Exp. Date 7/26 & A322302, Exp. Date 8/26
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations