PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 12, 2017 Initiated: June 8, 2017 #D-0949-2017

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.

Details

Recalling Firm
Phillips Co.
Units Affected
100-200 bottles
Distribution
Nationwide and United Kingdom
Location
Millerton, OK

Frequently Asked Questions

What product was recalled?
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. Recalled by Phillips Co.. Units affected: 100-200 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 12, 2017. Severity: Moderate. Recall number: D-0949-2017.