Drug product
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
D-0638-2026
Product summary
- Event
- Event 99137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5755 tubes
- Official record key
drug-enforcement:D-0638-2026
Official wording
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Code information: Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, Within Expiry.
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies