Recalls / Class II
Class IID-0951-2017
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
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
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.
Recalling firm
- Firm
- Phillips Co.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 311 Chikasaw Street, N/A, Millerton, Oklahoma 74750
Distribution
- Quantity
- 10-30 bottles/units
- Distribution pattern
- Nationwide and United Kingdom
Timeline
- Recall initiated
- 2017-06-08
- FDA classified
- 2017-07-06
- Posted by FDA
- 2017-07-12
- Terminated
- 2020-07-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0951-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.