Drug product
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.
D-0205-2026
Product summary
- Event
- Event 97935
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2592 bottles
- Official record key
drug-enforcement:D-0205-2026
Official wording
Reason: cGMP deviations
Code information: Lot #: A062434, Exp. Date 6/27 & A062449, Exp. Date 7/27
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations