Drug product
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
D-0203-2026
Product summary
- Event
- Event 97935
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18912 containers
- Official record key
drug-enforcement:D-0203-2026
Official wording
Reason: cGMP deviations
Code information: Lot #: A022310, Exp. Date 2/26; A022335, Exp. Date 10/26; A022406, Exp Date 12/27 & A022505, Exp Date 12/27
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations