Drug product
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
D-0207-2026
Product summary
- Event
- Event 97935
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7944 containers
- Official record key
drug-enforcement:D-0207-2026
Official wording
Reason: cGMP deviations
Code information: Lot #: A092421, Exp. Date 7/27, A092340, Exp. Date 10/26 & A092346, Exp. Date 11/26.
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations