The Recall Desk
SevereFDA (Drugs)·D-0948-2017·Announced 2017-07-12

TetraStem Topical Antibiotic Ointment Recalled for Manufacturing Deviations

Phillips Co. is recalling TetraStem Topical Ointment First Aid Antibiotic 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 FDA Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) or higher, regardless of whether specific injuries are reported in the text.

Plain-English summary

Phillips Co. is recalling TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle (NDC 04307-301-11). The product was sold over the counter and distributed nationwide and in the United Kingdom. The recall involves all lots remaining within their expiry date.

The recall was initiated following an FDA inspection that identified significant Good Manufacturing Practice (GMP) deviations. These findings 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 recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11
Manufacturer
Phillips Co.
Category
Drug — Topical Antibiotic
Hazard

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

Same manufacturer · Phillips Co.

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Same hazard · gmp deviation

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