D-0949-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 12, 2017
- Initiation Date
- June 8, 2017
- Termination Date
- July 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100-200 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide and United Kingdom
Code Information
All lots remaining within expiry.