TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11

Recall Number: D-0948-2017

Firm: Phillips Co.

Classification: Class II

Status: Terminated

Report Date: 20170712

Initiation Date: 20170608

Termination Date: 20200720

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.

TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11