Drug product
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.
D-0637-2026
Product summary
- Event
- Event 99137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1185 tubes
- Official record key
drug-enforcement:D-0637-2026
Official wording
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Code information: Lot# 022, 023 ,024, Within Expiry.
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies