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
Reported: July 12, 2017 Initiated: June 8, 2017 #D-0948-2017
Product Description
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
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.
Details
- Recalling Firm
- Phillips Co.
- Units Affected
- 200-300 bottles
- Distribution
- Nationwide and United Kingdom
- Location
- Millerton, OK
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Phillips Co.. Units affected: 200-300 bottles.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on July 12, 2017. Severity: Moderate. Recall number: D-0948-2017.
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