Drug product
StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01
D-0951-2017
Product summary
- Firm
- Phillips Co.
- Event
- Event 77526
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10-30 bottles/units
- Official record key
drug-enforcement:D-0951-2017
Official wording
Reason: GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Code information: All lots remaining within expiry.
Distribution pattern: Nationwide and United Kingdom
Derived failure modes
-
Manufacturing or process control
GMP Deviations