Phillips Co. recalls TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter…

Recall date

June 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0948-2017

FDA classification

Class II

Brand / firm

Phillips Co.

Sold / distributed

Nationwide and United Kingdom

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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