Phillips Tetracycline Ointment Recalled for Manufacturing Quality Concerns
Phillips Co. is recalling Tetracycline-ABC Brand Topical Ointment because FDA inspections found significant manufacturing deviations that raise questions about product safety and quality.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when significant manufacturing deviations raise questions about the safety and quality of the drug product.
Plain-English summary
Phillips Co. is recalling Tetracycline-ABC Brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle (NDC 43074-1020-1). The recall involves 100 to 200 bottles distributed nationwide and in the United Kingdom. All lots remaining within their expiry dates are affected.
The recall was initiated following an FDA inspection that identified significant Good Manufacturing Practice (GMP) deviations. These manufacturing practices call into question the safety, identity, strength, quality, and purity of the unexpired drug products manufactured by the firm.
Consumers who have this product should stop using it and contact Phillips Co. for further instructions or a refund.
The recalled product
- Product
- 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
- Manufacturer
- Phillips Co.
- Category
- Drug — Topical Antibiotic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Phillips Co. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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