Drug product
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.
D-0635-2026
Product summary
- Event
- Event 99137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1087 tubes
- Official record key
drug-enforcement:D-0635-2026
Official wording
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Code information: Lot# 007, 008, 009, 015, 016, Within Expiry.
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies