Drug product
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
D-0213-2026
Product summary
- Event
- Event 97935
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2400 containers
- Official record key
drug-enforcement:D-0213-2026
Official wording
Reason: cGMP deviations
Code information: Lot #: A482305
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations