Recalls / Class II
Class IID-0949-2017
Product
Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-100-11
- 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
- 100-200 bottles
- 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-0949-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.