Phillips Recalls Diabecline Topical Ointment Due to Manufacturing Deviations
Phillips Co. is recalling Diabecline brand Topical Ointment First Aid Antibiotic because FDA inspections found significant manufacturing deviations that question the product's safety and quality.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, particularly given the significant manufacturing deviations affecting product safety and quality.
Plain-English summary
Phillips Co. is recalling Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle (NDC 04307-100-11). 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
- 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
- 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.
See all 6 products in this recall →Related recalls
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