Drug product
Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4.
D-0630-2026
Product summary
- Event
- Event 99137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2503 tubes
- Official record key
drug-enforcement:D-0630-2026
Official wording
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Code information: Lot# 0002, Lot# 0003, within expiry
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations; deficiencies