Class I · High risk Terminated
Tetracycline HCL Capsules
Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
TetraStem brand Topical Ointment First Aid Antibiotic
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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.
What 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
- Recalling firm
- Phillips Co.
- NDC code
- 04307-301-11
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0948-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tetracycline recalls
See all
Class I · High risk Terminated
Tetracycline HCL Capsules
Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Class II · Moderate risk Terminated
Diabecline brand Topical Ointment First Aid Antibiotic
Reason 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.
Class II · Moderate risk Terminated
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic
Reason 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.
Class II · Moderate risk Terminated
Tetracycline HCl active pharmaceutical ingredient packaged in…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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