TetraStem Topical Ointment Recall: GMP Deviations Risk
Phillips Co. recalls TetraStem brand Topical Ointment due to GMP deviations affecting safety and purity. Check your bottle.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Phillips Co. is recalling TetraStem brand Topical Ointment First Aid Antibiotic because of significant Good Manufacturing Practice (GMP) deviations found during an FDA inspection. These manufacturing issues raise concerns about the safety, identity, strength, quality, and purity of the unexpired drug products. The recall affects 200-300 bottles distributed nationwide and in the United Kingdom. Read more at govinfonow.com/recall/41574-tetrastem-topical-ointment-recall-gmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41574-tetrastem-topical-ointment-recall-gmp-deviations-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0948-2017
Cite this page
“TetraStem Topical Ointment Recall: GMP Deviations Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41574-tetrastem-topical-ointment-recall-gmp-deviations-risk. Based on FDA recall #D-0948-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0948-2017%22&limit=1).
Why it’s dangerous
The hazard stems from significant GMP deviations that call into question the safety, identity, strength, quality, and purity of the drug. While the specific mechanism of injury is not detailed, compromised manufacturing practices can lead to ineffective treatment or contamination.
Who’s affected
Consumers who purchased TetraStem brand Topical Ointment First Aid Antibiotic, specifically those with NDC 04307-301-11, are affected. This includes individuals in the United States and the United Kingdom who bought the product over the counter.
How to tell if you have this one
Look for TetraStem brand Topical Ointment First Aid Antibiotic containing tetracycline (3%) in a 3 mL amount within a 5 mL bottle. The product has NDC 04307-301-11 and all lots remaining within their expiry date are included.
- Brand
TetraStem- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and United Kingdom
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0947-2017 | 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; All lots remaining within expiry. | 100-200 bottles |
| D-0948-2017 | 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; All lots remaining within expiry. | 200-300 bottles |
| D-0949-2017 | 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; All lots remaining within expiry. | 100-200 bottles |
| D-0950-2017 | StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11; All lots remaining within expiry. | 20-50 bottles/units |
| D-0951-2017 | StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01; All lots remaining within expiry. | 10-30 bottles/units |
| D-0952-2017 | VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01; All lots remaining within expiry. | 20-50 bottles/units |
What to do — step by step
Stop using the ointment
Discontinue use of the recalled TetraStem brand Topical Ointment due to potential safety and quality issues.
Check your product details
Verify if your bottle matches NDC 04307-301-11 and contains tetracycline (3%) in a 5 mL bottle.
Contact the manufacturer
Reach out to Phillips Co. for further instructions on disposal or return, as no specific remedy is currently stated.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide and United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0948-2017 (June 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0948-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.