FDA recall D-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

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

Nationwide and United Kingdom

Key facts

Status

Terminated

Initiation date

2017-06-08

Report date

2017-07-12

Termination date

2020-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Millerton, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0949-2017