CLASS II Drug recall · Reported 12 Jul 2017 · FDA Enforcement Report
Tetracycline-ABC Topical ointment First Aid Antibiotic recalled
Phillips is recalling Tetracycline-ABC Topical ointment First Aid Antibiotic, tetracycline (3%) in a, sold over, distributed nationwide in the US. The recall was initiated on 8 Jun 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0947-2017
- FDA event ID
- 77526
- Recalling firm
- Phillips, Millerton, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jun 2017
- FDA classified
- 6 Jul 2017
- Reported
- 12 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Processing Deviation
- Drug class
- Creams, Ointments & Gels
Timeline
| 8 Jun 2017 | Recall initiated by company | |
| 6 Jul 2017 | Classified by FDA | +28 days |
| 12 Jul 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201
Where it was distributed
Nationwide and United Kingdom
Questions about this recall
Is Tetracycline-ABC Topical ointment First Aid Antibiotic, tetracycline (3%) in a, sold over recalled?
Yes. Phillips recalled Tetracycline-ABC Topical ointment First Aid Antibiotic, tetracycline (3%) in a, sold over on 8 Jun 2017. The recall is Class II and its status is Terminated. Recall number D-0947-2017.
Why was it 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 lots are affected?
All lots remaining within expiry.
Where was it sold?
Nationwide and United Kingdom
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Phillips
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|---|---|---|---|---|---|
| Drug | CLASS II | Diabecline Topical Ointment First Aid Antibiotic recalled by Phillips | Phillips | Processing Deviation | Nationwide |
| Drug | CLASS II | StingMed Insect bites Skin Protectant recalled by Phillips | Phillips | Foreign Material | Nationwide |
| Drug | CLASS II | VenomX, Zinc acetate (.1% by volume) recalled by Phillips | Phillips | Processing Deviation | Nationwide |
| Drug | CLASS II | StaphWash+Plus+ Skin Protectant, Zinc acetate recalled by Phillips | Phillips | Processing Deviation | Nationwide |
| Drug | CLASS II | TetraStem Topical Ointment First Aid Antibiotic recalled by Phillips | Phillips | Processing Deviation | Nationwide |